Merck

Merck Careers Our work is someone's hope. Join us. At Merck, we believe in putting patients first in all we do. And we recognize that our employees are our single greatest asset in achieving this mission. Top 5 reasons our people are committed to working at Merck:

  • Quality of co-workers
  • Ethical standards and values
  • Merck's mission
  • Compensation and benefits
  • Work environment

At Merck, we have approximately 700 employees with military backgrounds working in 26 US locations. in areas such as Research & Development, Information Technology, Manufacturing, Finance, Sales & Marketing, Legal, Site Services, Human Resources and Six Sigma. We value the experience and technical knowledge that these individuals bring to our organization, in addition to their dedication, discipline, strong leadership skills and training.

Merck offers opportunities in various areas of our company for individuals with military experience. Merck has many employees with military backgrounds who work at several of our U.S. locations. We value their experience and technical knowledge, as well as their dedication, discipline, strong leadership skills and training.

May 25, 2018
Requisition ID: PRO017267 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.  The Vaccine Process Development and Commercialization (V-PDC) group within the Merck Manufacturing Division (MMD) focuses on late stage process development, technology transfer, and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs. In this role, you will be responsible for: Leading process development activities to execute large molecule upstream processing including lab-scale process development, in-process assay support, and process scale-up/scale-down. Execution of lab scale experiments and authoring associated technical reports and documents. Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within the Merck network and at contract manufacturing organizations (CMOs). Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner. Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure. Provide mentorship and technical direction to other members of the team which may include dotted-line reporting relationships. Qualifications Education Minimum Requirement: B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience. Required Experience and Skills**: Large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of upstream large molecule drug substance processes (aseptic-flasks, bioreactors, single use systems). Subject Matter Expertise with Upstream lab or pilot-scale fermenters/bioreactors/cell culture running microbial and/or mammalian cell based large molecule processing. Expertise in lab scale experimental execution and experience with Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions. Experience authoring technical documentation to support regulatory submissions. Outstanding communication and people skills. Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development. Experience with project strategic planning. cGMP experience. Preferred Experience and Skills: Knowledgeable in Drug Substance, end-to-end process development. Experience with upstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling. Experience with Quality by Design (QbD) and Lean Six Sigma principles Strong cross-functional background, enabling teams to reach peak performance. Ability to provide scientific mentorship and guidance to technical coworkers and colleagues within and outside of Merck. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA) Experience with on-the-floor GMP manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Process Engineering Other Locations: Employee Status: Regular Travel: Yes, 25 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Potential to work with BSL2 compunds, live virus vaccines, general laboratory chemicals. Will be required to enter core sterile manufacturing areas. Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: TEC001278 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The selected candidate will utilize the Sourcing Management Process for strategic analysis of suppliers, supply markets and supply chains within the Clinical Specialty Services of Research and Development Sourcing and Procurement.  The selected candidate will work to provide high quality strategic analysis, insight of suppliers and markets.  The manager will prepare and conduct pre-negotiation planning, live negotiations as well as leading and conducting RFIs, RFPs, quotation analysis, and cost modeling.   Primary activities include, but are not limited to: Supplier and Supply Market Analysis – conduct detailed supplier and supply market analysis, including changes in technology and pricing trends, with a view to providing deep and meaningful insights to Sourcing Management teams. Cost Modeling – construct detailed cost models/purchase price analysis of services that are supplied to Merck; this may include supplier visits to create a complete understanding of the cost structure of suppliers. Strategic Analysis – conduct various forms of project analysis which turns the information into insightful, well-structured breakthrough options and opportunities.  Negotiation Planning and Execution – create detailed pre-negotiation plans. Lead and participate in negotiation sessions with suppliers and conduct post negotiation debriefs and follow through plans. Sourcing – create and execute RFIs/RFPs/RFQs together with subsequent structured information analysis using SAP, e-sourcing, MS Office and other computer based systems. Reverse Auctions –prepare, lead, conduct and implement Reverse Auctions on selected leverage categories. Contract Management – prepare, finesse and implement appropriate forms of contract and commitment with suppliers. Supplier Performance Management – build relationships with suppliers and work with internal stakeholder groups to manage supplier performance against business requirements (governance, scorecarding, etc).  Monitor, report, manage and continuously improve supplier performance. Sharing of Learning – the incumbent will be expected to generate world-class sourcing deliverables and share best practices to colleagues throughout Procurement. Qualifications Education Minimum Requirement: B.S. in Business, Science or Engineering.  Required Experience and Skills:   Minimum of  3-5 years of Procurement, Scientific or relevant experience Preferred Experience and Skills:   Advanced degree Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement Job: Technical Procurement Other Locations: Kenilworth, NJ, US Employee Status: Regular Travel: Yes, 5 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: None Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: ACC004850 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck’s Global Human Health (GHH) Division abides by a “patient first, profits later” ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The organization is comprised of sales and marketing professionals who are passionate about their role in bringing Merck's prescription medicines, vaccines, and other medical products to our customers worldwide.  Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products.  Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.   Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Virology Community Liaison is a key member of the Virology Team in the Global Human Health Division. The incumbent plays a critical role in supporting Merck's customer centric business model. The Community Liaison will be responsible for the following:  Engaging Allied Healthcare Professionals (AHP) and Patient Advocates in the assigned geography and taking the lead on all local community related initiatives. Establishing strong partnerships with institutions serving the healthcare needs of the community such as Community Based Organizations (CBO), Service Organizations and clinics to provide relevant resources to the AHPs in those institutions (i.e. Case Managers, Treatment Educators, Adherence Counselors, Social Workers, and others) Supporting the training needs in these institutions by providing educational resources designed to increase patient understanding of select virology related disease states, available treatment regimens, and optimal approaches to disease management. Collaborating with the local sales and marketing teams to provide information on Merck's access programs and medications that is consistent with government approved indications and brand messages to allied healthcare providers in a culturally sensitive manner Communicating and demonstrating a compelling and consistent vision of Merck's commitment to patients. Providing timely feedback on product/market conditions to a wide variety of internal customers including marketing and public affairs.   Ensuring all activities are within Merck policy and meet legal and compliance requirements. This position will be based in North Carolina or South Carolina and covers North Carolina, South Carolina and southern Virginia. Qualifications BS/BA degree required; Science or Healthcare major and/or Advanced Science, Public health or Allied healthcare degree preferred. Minimum of 2 years experience working in the field of Virology (CBO, Clinic, Pharmaceutical Company) Previous pharmaceutical industry experience (i.e. Sales, Marketing or Community Relations) and/or experience working in patient education is required.  Strong understanding of the HIV and HCV therapeutic areas and the current marketplace. Ability to understand, distill and communicate complex scientific and public health related concepts at an appropriate literacy level to diverse audiences. Strong presentation and training skills Excellent interpersonal skills with ability interact with individuals from a variety of cultures, and disciplines.  Self motivated with the ability to perform with a high level of independence. Ability to prioritize and organize effectively. Fluent in conversational and written English. Spanish or other second language is a plus. Proficient in Microsoft Excel, Powerpoint, Word and Outlook Required Experience and Skills:  Minimum of 2 years experience working in the field of Virology (CBO, Clinic, Pharmaceutical Company) Previous pharmaceutical industry experience (i.e. Sales, Marketing or Community Relations) and/or experience working in patient education is required. Strong understanding of the HIV and HCV therapeutic areas and the current marketplace. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Account Management Generic Other Locations: SC, US; VA, US Employee Status: Regular Travel: Yes, 75 % of the Time Number of Openings: 1 Shift (if applicable): N/A Hazardous Materials: None Company Trade Name: Merck
Merck North Carolina, NC, US
May 25, 2018
Requisition ID: PRO017159 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Functioning as a key member of the process development team through executing lab-scale process development, in-process assay support, and process scale-up or scale-down of cell culture/fermentation (upstream) and/or purification (downstream) process unit operations. Functioning as a key team member to collaborate with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within the Merck network and at contract manufacturing organizations (CMOs). Executing assignments against accelerated, critical-path timelines in a right-first-time manner. Authoring technical documents to support Process Performance Qualification (PPQ) and licensure. Participating in technical support activities for licensed vaccines, as needed Qualifications Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .    Position Qualifications: Education Minimum Requirement:     B.S. in Chemical Engineering, Chemistry, Biology or comparable discipline, with a minimum of 2 years relevant work experience.   Required Experience and Skills**: Experience with upstream lab or pilot-scale microbial or cell culture process (fermenters, bioreactors, static cell culture) and/or experience with large molecule purification (chromatography, filtration, centrifugation). Experience with process development in a laboratory setting. Experience within pilot-scale, or manufacturing environment. Experience authoring technical documentation to support regulatory submissions. Preferred Experience and Skills: Experience with large molecule commercialization (facility start-up, technology transfer). Experience with large molecule manufacturing and on-the-floor manufacturing support. Experience with large molecule assay development and execution (HPLC, UPLC, MS). Proven ability to work independently and as part of a team and execute against key commitments. Strong problem solving and communication skills. Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement Job: Process Engineering Other Locations: West Point, PA, US Employee Status: Regular Travel: Yes, 25 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: BSL2 compunds, live virus vaccines, general laboratory chemicals Company Trade Name: Merck
Merck United States, US
May 25, 2018
Requisition ID: MAR006949 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck’s Global Human Health (GHH) Division abides by a “patient first, profits later” ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The organization is comprised of sales and marketing professionals who are passionate about their role in bringing Merck's prescription medicines, vaccines, and other medical products to our customers worldwide.  This individual will lead the development and delivery of integrated marketing communications plans and multi-channel programs, supporting the strategic imperatives for the Oncology Franchise. This position is a primary contact for the Lenvima Team for Oncology, responsible for marketing communications / promotion to external customers. This individual will convert emerging scientific data in oncology into a communication for customer segments, channels,  Responsibilities include, but are not limited to the following: Significant contributions to the brand building tools. The development of a communications strategy that is aligned to the integrated brand/customer strategy and fully leveraging all available channels to deliver a positive customer experience. Drive measurement and improvement of promotional effectiveness across the integrated promotional mix and relevant customer segments. Drives marketing effectiveness by creating programs that drive desired customer behaviors, yielding increased revenue. All activities will be conducted in full compliance with Merck policies, values and standards. Lead the development of integrated promotion plans, promotional content for Lenvima, and coordinates content strategy across all channels  Deliver promotional product, new indication or new formulation launch plans highlighting interdependencies with other relevant functional areas such Market Research and Learning. Core participant in shaping the key strategic communication objective choices for assigned business/brand(s). Partner with the brand team and assigned external agencies to ensure that all offerings meet the strategic and communication objectives for oncology. Help to shape the strategic direction of the global portfolio through active participation with Merck Marketing meetings, and other forums with Regional leaders. Demonstrate operational efficiency by leveraging best practices and facilitating cross-Region learning Know the customer: demonstrate a deep understanding of customer segments, needs, channel preferences and profitability/life-time value. Lead the creation and monitoring of Agency scopes of work (SOWs) and leads the bi-annual Agency evaluation process. Accountable for the operational proficiency of assigned Agencies and other channel outsourced vendors. Apply the Merck Marketing and Merck Customer Experience principles, during the promotional planning and development process. Work collaboratively with multiple teams including the Market Research, Analytics, and Operations as well as the Franchise leads. Manage projects and programs through appropriate internal and external support services in development of content, design, Promotional Review Team (PRT) approvals, and production. Oversee the appropriate administration of promotional budgets for projects and deliverables. Demonstrate Merck Leadership Behaviors. Act as a business owner in the operating environment. Maintain alignment to compliance goals and policies. Qualifications Education Minimum Requirement:   Bachelor's Degree required  Required Experience and Skills:   Minimum of 4 years experience in marketing or marketing support of pharmaceutical products. Demonstrated ability to execute a brand or customer marketing strategy. Experience and success in cross-functional leadership and teamwork. Strong knowledge of marketing principles. Marketing/Marketing support in Oncology and/or Specialty marketplace. Campaign and Message Development experience. Constituency Management across hierarchial lines. Excellent planning and presentation skills    Preferred Experience and Skills:   Masters in Business Administration Knowledge/experience with the Oncology Marketplace. Product launch or launch planning experience. Agency management experience. Market research experience. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Marketing Communications/Channels ONC Other Locations: Employee Status: Regular Travel: Yes, 20 % of the Time Number of Openings: 1 Shift (if applicable): N/A Hazardous Materials: None Company Trade Name: Merck
Merck Upper Gwynedd, PA, US
May 25, 2018
Requisition ID: ENG003952 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Applied Computing Lead Engineer is responsible for contributing to and leading a team providing engineering support for diverse pharmaceutical research applications and workflows. Computational Platforms is an organization in the MRL-IT Engineering organization providing a unique combination of technology, infrastructure, software and personnel to support large scale scientific computing and comprises of the Model Lifecycle Management Platform, Scientific Methods Platform, High Performance Computing (HPC) Platform, and the Applied Computing capability. This technical role requires deep knowledge and experience in both computer science and life sciences research that will help bring a computer science approach to delivering solutions supporting pMerck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve nharmaceutical research. The position will be partly embedded in the research organization requiring a high degree of familiarity and comfort working with such groups. The successful candidate will be expected to ‘hit the ground running.’ The key activities for this role include: Providing hands-on leadership around the use and support of the Model Life cycle Management Platform, Scientific Methods Platform and HPC Platform Identifying key opportunities to provide value to the scientific organization by creating and delivering novel software, algorithmic or infrastructure solutions to complex and relevant scientific problems in discovery research Optimizing performance of scientific algorithms and workflows  Pinpointing and addressing critical gaps in the Computational Platforms, vetting potential technologies, and informing business impact-driven decisions on software and infrastructure Collaborating with other Platform leaders to integrate technologies across the IT organization   Qualifications Education Minimum Requirement: M.S. or Ph.D. Degree in Chemistry, Biology, Pharmacology, or related science, with a Computer Science background (B.Sc. or higher) Required Experience and Skills: Minimum of 5 years of relevant work experience in drug discovery Ability to architect, engineer, optimize and maintain software, algorithmic and infrastructural solutions to complex scientific problems Expert knowledge of the state-of-the-art for computational chemistry and cheminformatics, and application in drug discovery Experience with workflow technologies (e.g. Orion, Pipeline Pilot, etc.) and developing and deploying scientific methods as workflows Experience with domain-specific scientific software and toolkits (e.g. OpenEye Toolkits, MOE, Schrodinger Python API, Pipeline Pilot Chemistry SDK, etc.) Demonstrated experience with programming and scripting languages (Python, Java, C/C++) Experience with developing and using Web Services and RESTful APIs Troubleshooting issues in enterprise applications  Proficiency in LINUX and Windows operating systems Demonstrated ability to clearly communicate technical and non-technical information verbally and in writing Demonstrated ability to work with a diverse group of professionals globally Preferred Experience and Skills: Experience in configuration, tuning, deployment of Application/Web servers such as Tomcat etc. Knowledge of UI design particularly for scientific computation and visualization UI development experience with HTML, AJAX, Javascript/JQuery and similar technologies Knowledge of development on High Performance Computing systems Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement Job: Engineering, Development & Integration Other Locations: Boston, MA, US; Kenilworth, NJ, US; Upper Gwynedd, PA, US; West Point, PA, US; Rahway, NJ, US Employee Status: Regular Travel: Yes, 20 % of the Time Number of Openings: 1 Shift (if applicable): Hazardous Materials: No Company Trade Name: Merck
Merck South San Francisco, CA, US
May 25, 2018
Requisition ID: REG003104 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.    Under the guidance of a Global Regulatory Affairs - CMC Director, the Senior Specialist will work within a team to lead and execute change control assessments, develop and execute regulatory strategies, plan, track, author, review and gain approval for global post approval changes.  The Senior Specialist responsibilities include but are not limited to: Participation in the authorization process to prioritize submissions. Knowledge of global CMC guidelines regarding post approval changes. Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines. Development and execution of detailed, global regulatory strategies for submission and approval of post approval change documentation according to defined timelines. Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply. Lead authoring of clear, concise and effective global post approval submissions according to defined timelines. Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions. Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate. Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required  Qualifications Education: Bachelor’s degree in Biology, Chemistry, Engineering, or a related discipline  Required: At least two (2) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing or a related field.  Proficient in M.S. Word  Adept at use of assessment, planning and tracking systems  Capability to work effectively in matrix organizational structures  Demonstrated flexibility in responding to changing priorities or dealing with unexpected events  Preferred: Experience with post approval changes in Biologics or Vaccines Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. <?xml:namespace prefix = "o" />   If you need an accommodation for the application process please email us at staffingaadar@merck.com.    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Regulatory Affairs - CMC Other Locations: Employee Status: Regular Travel: Yes, 10 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck
Merck Kenilworth, NJ, US
May 25, 2018
Requisition ID: CLI007387 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.    Position Description:   The Program Manager oversees the successful execution of the clinical data management strategy for one or more drug or vaccine programs.    The Program Manger is accountable for ensuring Global Data Management regulatory submission deliverables are available for all in-scope trials including all aspects of the project plan (from protocol planning through data management submission components) are executed on time and with appropriate quality across their assigned programs.  Acts as the single point of contact and represents Global Data Management on cross-functional program teams and in other program-level development forums.   Able to work independently or as a team member or leader with equal effectiveness.  Interacts with staff across multiple Merck sites globally.  Mentors, guides, and provides project leadership for junior staff as assigned.   Primary Activities:                                                                      Oversees the data management strategy and project plans for collection and integration of all clinical data management deliverables (including, but not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes) for one or more drug or vaccine development programs.  Works with other groups to coordinate these deliverables. Partners with functional area representatives to ensure appropriate use of database standards and program-level consistency on database, data collection, review, and retrieval specifications. Serves as project manager of all data management activities for trials and/or programs as assigned. Provides program-related oversight and guidance to Trial Managers, and ensures quality and consistency of data management requirements and deliverables, through archival, across trials within a program. Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:  Project plan development, execution, and change control  Project team development, resource planning, and cost estimating Risk management (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control), including engagement with leads and managers for issue resolution and escalation as necessary Communications planning, information distribution, performance reporting, and project closure In-licensing due-diligence assessment Management of customer / stakeholder expectations; facilitation of cross-functional decisions. Keeps abreast of project and clinical data management disciplines through interaction with experts both within and outside of Merck. Identifies and develops improvements to data collection and data management processes and tools.  May lead a continuous improvement special project, or any other data management tasks deemed appropriate by management. May serve as Trial Manager for one or more trials within assigned programs.   Qualifications Education Minimum Requirement:    Bachelor's degree, preferably in life sciences, computer science, or related discipline.  Required Experience and Skills At least 6 years’ of proven leadership experience in Clinical Data Management discipline; Full life-cycle experience in clinical data management (data collection system development through database lock/close-out and submission including health authority inspection and audit support);  At least 3 years’ proven experience working with formal project management tools (ie. MS Project) and processes. Preferred Experience and Skills: At least 2 years' experience/exposure working in the Oncology, Bone, Respiratory, and/or Immunology Therapeutic areas; Knowledge of the clinical development process with in-depth knowledge of the Clinical Data Management lifecycle through submission deliverables.  Able to work independently and as a member of team with equal effectiveness.  Demonstrated team leadership and project management skills.  Proven strong organizational and problem-solving skills.  Proven effective communication skills both orally and written with both technical and business areas.  Experience with managing outsourced and/or licensing arrangements preferred. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. <?xml:namespace prefix = "o" />   If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Clinical Data Management Other Locations: Rahway, NJ, US Employee Status: Regular Travel: Yes, 5 % of the Time Number of Openings: 3 Shift (if applicable): N/A Hazardous Materials: No Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: SER001563 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.  You will be an active member of the Merck Research Laboratory Information Technology (MRLIT) Engineering team, delivering leading edge applications and services in the Translational Medicine domain. You will contribute in a technical role that requires deep knowledge and experience with programming and will work closely with architects, business analyst to design and implement software tools used in scientific workflows. You will understand and engage with world-class scientists in the research space and IT colleagues to deliver the tools and services needed to drive world-class research. Qualifications Education Minimum Requirement: MSc Degree or BSc Degree or equivalent work experience, with relevant experience in Computer Science, Computer Science Engineering, Math, or equivalent experience.  Required Experience and Skills : 8+ years of relevant work experience, preferably including leading small to medium teams of developers.  Experience with delivering complex software development projects Experience with Agile Development Principles.  Experience with various bug tracking and planning systems such as Jira.  Ability to interpret architecture designs and to abstract and define interfaces.  Hands-on experience with a service oriented approach including RESTful services.  Experience with Translational Medicine domains including Genetics, Genomics, Imaging or Biomarker research. Preferred Experience and Skills: Excellent attention to detail and a passion for continuous improvement.  Ability to understand strategic IT goals in order to be able to execute own tasks in support of technology integration initiatives.  Ability to work independently, asynchronously (across time zones) and with excellent communication skills that cross language/culture/geographic boundaries Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement Job: Service Delivery/Management Other Locations: Rahway, NJ, US; West Point, PA, US Employee Status: Regular Travel: Yes, 20 % of the Time Number of Openings: 1 Shift (if applicable): Hazardous Materials: No Company Trade Name: Merck
Merck Boston, MA, US
May 25, 2018
Requisition ID: MAN005279 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.  The primary purpose of this position is to lead a team of production technicians who perform basic laboratory procedures and to assist others in more advanced procedures for the production of veterinary biologicals according to strict government and company imposed guidelines.   The lead tech will work closely with the operations manager to ensure the department is able to meet production demands.  Requires the ability to train and assist in all areas of the production of RNA (RP) Particle Vaccine products manufactured in a USDA licensed facility.  Maintains the production schedule and reports performance of department through tiered site structure.  Assists in investigating process deviations and developing/implementing agreed upon CAPAs.   Strong communication skills are required. This position is accountable for the performance of the assigned work team and requires the ability to make independent decisions to enable the team to be successful.  Work activities include but are not limited to: Production of RP products for USDA licensure Assist in the review and maintenance of departmental SOPs Train and mentor production team Ensure schedule adherence of department Investigate deviations and develop/implement CAPAs Maintain working knowledge of product outlines Maintain laboratory equipment Maintenance of Vero cell line and related cell culture activities Assist with electroporation process Assist with RP harvest and formulation Final serial formulation and fill Maintains production records according to regulations Updates training record as needed Perform other duties as required Qualifications Education Minimum Requirement:  Associates Degree in Biology, Microbiology, or related science or High School diploma with 3 years relevant work experience Required Experience and Skills:  Must have strong attention to detail Must exhibit strong communication skills Must be an effective trainer Must be able to work independently, and seek direction, as needed Must have ability to follow verbal and written instructions Must have good mathematical abilities Must have experience in laboratory technique  Must have experience following approved protocols and standard operating procedures (SOPs) Preferred Experience and Skills: Experience working in a manufacturing or laboratory setting preferred but not required Leadership experience is preferred but not required Aseptic experience preferred but not required Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Manuf./Operations Generic Other Locations: Employee Status: Regular Travel: Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Bleach Company Trade Name: Merck
Merck Ames, IA, US
May 25, 2018
Requisition ID: BIO005017 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.  We currently have an exciting opportunity to join our Bioprocess Research & Development team located at our West Point, PA site.  This position supports Merck's discovery & development efforts for programs in the Department of Vaccine Analytical Development at West Point, PA. The incumbent is responsible for development and execution of analytical methods and procedures to support process and formulation development, and/or release, stability and characterization of vaccine products. The incumbent will either perform this work directly or will develop and supervise a group of 0-5 associate level scientists.   Specific duties will include:  Development, optimization, validation & implementation of cell based assays (bioassays) for recombinant, conjugate & live-virus-based vaccines  The design & implementation of rugged analytical cell based assays, meeting aggressive project timelines  Active participation in cross-functional teams  Preparation of documentation for regulatory submissions Project leadership Qualifications Education:  A Ph.D. in Virology, Biology, Immunology or related fields. Required:  In-depth knowledge and understanding of biochemical/biological assays and possess strong scientific & technical leadership skills. Minimum of four (4) years of bio-pharmaceutical experience in the development and validation of cell-based assays for proteins or vaccines. Understanding and practical knowledge of GMPs as applied to analytical requirements.  Excellent verbal & written communication skills.  Strong awareness of industry/regulatory trends.  Knowledge of emerging technologies. Preferred: Experience of project leadership is desirable. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Biologics, Vaccines, Analytical Formulat Other Locations: Employee Status: Regular Travel: Number of Openings: 1 Shift (if applicable): Hazardous Materials: Dengue virus, RSV and CMV Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: MAR006948 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck’s Global Human Health (GHH) Division abides by a “patient first, profits later” ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The organization is comprised of sales and marketing professionals who are passionate about their role in bringing Merck's prescription medicines, vaccines, and other medical products to our customers worldwide.  This individual will lead the development and delivery of integrated marketing communications plans and multi-channel programs, supporting the strategic imperatives for the Oncology Franchise. This position is a primary contact for the Lynparza Team for Oncology, responsible for marketing communications / promotion to external customers. This individual will convert emerging scientific data in oncology into a communication for customer segments, channels,  Responsibilities include, but are not limited to the following: Significant contributions to the brand building tools. The development of a communications strategy that is aligned to the integrated brand/customer strategy and fully leveraging all available channels to deliver a positive customer experience. Drive measurement and improvement of promotional effectiveness across the integrated promotional mix and relevant customer segments. Drives marketing effectiveness by creating programs that drive desired customer behaviors, yielding increased revenue. All activities will be conducted in full compliance with Merck policies, values and standards. Lead the development of integrated promotion plans, promotional content for Lynparza, and coordinates content strategy across all channels  Deliver promotional product, new indication or new formulation launch plans highlighting inter dependencies with other relevant functional areas such Market Research and Learning. Core participant in shaping the key strategic communication objective choices for assigned business/brand(s). Partner with the brand team and assigned external agencies to ensure that all offerings meet the strategic and communication objectives for oncology. Help to shape the strategic direction of the global portfolio through active participation with Merck Marketing meetings, and other forums with Regional leaders. Demonstrate operational efficiency by leveraging best practices and facilitating cross-Region learning Know the customer: demonstrate a deep understanding of customer segments, needs, channel preferences and profitability/life-time value. Lead the creation and monitoring of Agency scopes of work (SOWs) and leads the bi-annual Agency evaluation process. Accountable for the operational proficiency of assigned Agencies and other channel outsourced vendors. Apply the Merck Marketing and Merck Customer Experience principles, during the promotional planning and development process. Work collaboratively with multiple teams including the Market Research, Analytics, and Operations as well as the Franchise leads. Manage projects and programs through appropriate internal and external support services in development of content, design, Promotional Review Team (PRT) approvals, and production. Oversee the appropriate administration of promotional budgets for projects and deliverables. Demonstrate Merck Leadership Behaviors. Act as a business owner in the operating environment. Maintain alignment to compliance goals and policies. Qualifications Education Minimum Requirement:  Bachelor's Degree required  Required Experience and Skills:   Minimum of 4 years experience in marketing or marketing support of pharmaceutical products. Demonstrated ability to execute a brand or customer marketing strategy. Experience and success in cross-functional leadership and teamwork. Strong knowledge of marketing principles. Marketing/Marketing support in Oncology and/or Specialty marketplace. Campaign and Message Development experience. Constituency Management across hierarchial lines. Excellent planning and presentation skills    Preferred Experience and Skills:   Masters in Business Administration Knowledge/experience with the Oncology Marketplace. Product launch or launch planning experience. Agency management experience. Market research experience. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Marketing Communications/Channels ONC Other Locations: Employee Status: Regular Travel: Yes, 20 % of the Time Number of Openings: 1 Shift (if applicable): N/A Hazardous Materials: None Company Trade Name: Merck
Merck Upper Gwynedd, PA, US
May 25, 2018
Requisition ID: ENV000566 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Provides technical expertise, guidance and overall support in the site's compliance with federal, state and local water regulations at the Danville site including Waste Water Treatment Plant (WWTP), potable water, storm water and other environmental regulatory topics. Be the Hazardous and Solid Waste Amendment (HSWA) expert on site. Performs responsibilities and addresses problems in a proactive way. Integrates Environment, Health and Safety (EHS) programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives. Will be the EHS point of contact with operations, mainly Engineering and Maintenance department. Knowledge in air and waste regulation are a plus to assist the rest of the environmental team.  With a deep knowledge of EHS regulations and their applicability coordinate, guide, review and oversee implementation of site water quality program, training, presentations, policies and procedures.  Analyze data and prepare water permit applications for submittal to state and federal environmental agencies. Applications include National Pollutant Discharge Elimination System (NPDES), HSWA permits as applicable for the site’s current and future projects.  Review and verify all the reports sent to external agencies.  Possess experience with EHS agency inspections and regulatory advocacy.  Review and analyze water permits to evaluate compliance and improvements  Verify compliance with regulations and ensure all required records, reports, notifications, etc. are maintained, prepared, and/or submitted in accordance with established guidelines and/or regulatory deadlines. Recommend changes if compliance gaps are identified. Work with stakeholders to develop solutions to issues and to develop improvements. Track implementation.  Responsible for periodically reporting metrics to site and Company management on the effectiveness of the program implementation and changes or improvements being implemented.  Be the EHS point of contact for the Engineering and Maintenance department. Provide support in completing incident and near miss analysis, training, inspections, self-assessments and addressing specific EHS concerns as they are raised.  Be the environmental point of contact for all the site projects (capital projects).  Participate in regulatory inspections and internal audit processes.  Analyze, interpret and distill data and information to support submittals to regulatory agencies and to explain requirements and best implementation practices to internal clients.  Remain current with all environmental regulations and as they apply to our industry. Identify the environmental requirements.  At times, direct the activities of third party EHS or Legal consultants to prepare necessary permit applications or other required studies compliance materials.  Work with company center of expertise for any compliance projects and issues regarding the Water programs.  Be part of the site Emergency Operation Center (EOC) team as environmental expert (will have a pager in case of environmental issue).  Complete work assignments and to achieve department goals/objectives.  Support waste and air programs as needed.   Qualifications Education Minimum Requirement: Bachelor’s Degree in Environmental Engineering, Environmental Science, Chemical Engineering, Chemistry or similar environmentally related discipline required. Required Experience and Skills: Minimum 5 years applied professional EHS work experience, including water program compliance as a must.  Advanced level of proficiency in the areas of water especially industrial WWTP, permitting, negotiating with regulatory agencies, and supporting EHS agency inspections.  Proficient in critical thinking, communication skills, project management and MS Office suite (Word, Excel, Power Point). Preferred Experience and Skills:  Pennsylvania-specific permitting and environmental agency experience preferred.  Experience in a pharmaceutical, chemical industry or utility environment a plus.  Experience in Air and Waste programs   Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .   Search Firm Representatives Please Read Carefully:   Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement Job: Env, Health & Safety Generic Other Locations: Employee Status: Regular Travel: No Number of Openings: 1 Shift (if applicable): Hazardous Materials: Danville site is an API site with antibiotics and presence of numerous hazardous raw materials and wastes. Company Trade Name: Merck
Merck Danville, PA, US
May 25, 2018
Requisition ID: REG003103 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.    Director will provide regulatory leadership, oversight and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for post approval biologics.  This includes preparation of applicable sections of post approval supplements (Variations), Agency Background Packages, and responses to Agency questions for global markets. The primary focus of the position is providing direction to team members responsible for developing and executing implementation of regulatory strategies, and making decisions that ensure the high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes assessment for strategic projects and for routine changes, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence and incorporating knowledge of the changing regulatory environment. This individual will be responsible to build the post approval biologics CMC by hiring, mentoring and coaching team members. In conjunction with peers, the individual will be involved in development of tools that enable the optimization of the CMC regulatory function. In addition to routine administrative tasks, this individual will also be involved in assessment and development of talent within the organization.   Responsibilities: Accountable for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.  Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges.  Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations. Embody the Merck Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.  Continuously evaluate and develop talent within the team and prepare a succession plan. Use recognition and rewards to promote team and organizational collaboration.  Hold employees accountable for execution of departmental policies and procedures. Flexibly manage and allocate resources within area to support execution and delivery of prioritized work to meet business commitments. Actively sponsor employees who lead and participate in Merck initiatives.  Cultivate and foster strong collaborative relationships with stakeholders and partners across the organization.  Represent the department’s needs and positions in senior leadership forums. Qualifications Education Requirement:   Degree in pharmacy, chemistry, engineering or a related discipline; post-graduate degree preferred..  Required Experience: Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree.  Minimum 5 years working in Regulatory CMC, including the development stages of the product life cycle. Minimum 3 years managing people.  Preferred Experience:     The ideal candidate will have strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance) and experience managing a team of Regulatory CMC professionals.  A candidate with strong experience in Biologics pre/post approval expertise is highly preferred.  The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.  He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.  The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts. The candidate must have demonstrated experience in building, rewarding and retaining key talent. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.  The candidate must be proficient in English; additional language skills are a plus.   Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. <?xml:namespace prefix = "o" />   If you need an accommodation for the application process please email us at staffingaadar@merck.com.    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Regulatory Affairs - CMC Other Locations: Kenilworth, NJ, US Employee Status: Regular Travel: Yes, 10 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: PRO017203 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck’s Global Human Health (GHH) Division abides by a “patient first, profits later” ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The organization is comprised of sales and marketing professionals who are passionate about their role in bringing Merck's prescription medicines, vaccines, and other medical products to our customers worldwide.  The Vaccine Process Development and Commercialization (V-PDC) group within the Merck Manufacturing Division (MMD) focuses on late stage process development, technology transfer, and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs. In this role, you will be responsible for: Oversee and lead technical teams in developing and executing vaccine purification and other bioprocesses related to pipeline commercialization, life cycle management of the existing vaccine portfolio, and deviation investigations.  Interface closely with process, formulation, analytical, manufacturing, quality, and regulatory groups to develop and execute on long-term strategies and product trajectories.  Be the primary point of contact in managing relationships with senior leadership, outsourced organizations, and health authorities. As a critical aspect of this role, you will teach, mentor, coach, and provide technical guidance. You will focus on expanding and evolving our culture of continuous learning and improvement through collaborations with manufacturing and research organizations. Direct management of a small team of scientists Qualifications Education Minimum Requirement: B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 14 years of relevant experience OR Master's degree  in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience OR Ph.D. with 8 years of relevant experience. Required Experience and Skills**: Expert in large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of downstream large molecule drug substance downstream processes (lysis, normal and tangential-flow filtration, chromatography, continuous centrifugation, precipitation, and conjugation chemistry). Recognized SME with deep technical knowledge and in-depth experience with downstream process development & commercialization with ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development. Extensive experience in various lab scale process models from high throughput to small scale, manufacturing representative models. Ability to drive programs and experiments in the context of long-term commercialization plan. Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles. Minimum 2 years of direct people management experience Strong track record leading cross-functional, strategic initiatives Strong track record mentoring colleagues in direct an matrix organizations including minimum 2 years of direct people management Preferred Experience and Skills: Large molecule downstream process development expertise with multiple vaccine or biologics platforms including: recombinant protein, live viral, polysaccharide, and conjugate Knowledgeable in Drug Substance, end-to-end process development.  Strong track record of effective collaboration across internal manufacturing and research divisions and with external academic and/or government research institutions. Recognized internationally as subject matter expert in large molecule drug substance purification (history of peer-reviewed publications and as invited speaker on these topics). Strong understanding of regulatory filing requirements (IND, MAA, BLA) with multiple agencies (FDA, EMA, JNDA, TGA). Prior experience with process transfer to internal and external manufacturing partners Advanced computer skills using statistical packages (JMP, MiniTab, etc)  Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Process Engineering Other Locations: Employee Status: Regular Travel: Yes, 25 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Some work with biosafety-level 2 organisms Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: ADM009452 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.  The position functions as a part of the MMR & Varicella Focus Factory at the Durham, NC Hilleman Center. This position reports to the Executive Director of the Focus Factory and supports administrative activities associated with the various Focus Factory and site wide initiatives.  This position requires the ability to work independently with minimal supervision, produce/complete various assignments requiring advanced analytical ability, demonstrate independent judgment, creativity and problem solving skills. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers, above site planning, vendors) sites to support these initiatives.   KEY RESPONSIBILITIES INCLUDE (BUT NOT LIMITED TO): Conduct research, analyzes and reviews data, and recommends action from various reports and/or statistics. Develop reports, tables, graphs, presentations and correspondence. Demonstrated knowledge of Microsoft programs (Word, Excel, Powerpoint, etc) is required. May be responsible for various systems and requires in-depth knowledge of specialized confidential software applications such as Employee Data Management [HtR], Job Placement [Career Link], Financial systems [EZ Buy, EZ Expense, and my eTrip], SOP administration system [MIDAS], CMMS [Maintenance Management], MRP [Materials Requirement Planning], etc. Position may include business unit specific assignments; i.e., SOP administration, CMMS database, coordination of environmental regulatory programs, coordination of regulatory inspections, MRP system, etc. Responsible, where applicable, for coordinating various events such as regulatory inspections and hosting site visits. Coordinate site celebrations. Coordinate travel arrangements. Assist with the coordination of community relations Coordinate and/or facilitates key meetings, including meals, and schedules. Coordinate interview schedules and creation of interview packets. Maintain training reports, assign lockers, manage GMP access request requests and / or special assignments by manager. Maintain area specific printers and office supply stock  Qualifications Education Minimum Requirement:  High School Diploma or GED Required Experience and Skills**:  Work priorities and activities are performed independently with minimal supervision. Communication skills must be at a level to effectively interact with internal/external customers to manage projects, assignments, and workflow. Ability to perform complex administrative functions  Proficient in Microsoft Office including Excel and PowerPoint.  Preferred Experience and Skills: Advanced computer skills and operation of other peripheral devices.  Associate’s degree preferred Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. <?xml:namespace prefix = "o" />   If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Administrative Svcs Generic Other Locations: Employee Status: Regular Travel: Yes, 5 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: no Company Trade Name: Merck
Merck Durham, NC, US
May 25, 2018
Requisition ID: BIO005099 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.  The Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) at West Point is seeking an experienced assay development scientist to join the Regulated Bioanalytical group. The primary role of the successful candidate will be to provide scientific expertise and assay development for novel DNA/RNA therapeutics and vaccines.  In addition, the successful individual should be able to provide strong scientific strategy into novel assay methodologies and platforms using state of the art technologies suitable for Regulated work.   The successful candidate will be a scientific leader, with a passion for developing assays, delivering high quality data, and helping teams choose the right assays for data-driven decision making.  A record of accomplishment of successful collaboration while working in cross-functional project teams is expected. The successful candidate will also have responsibility for mentoring, scientific supervision, and training scientists, as well as contributing to setting Regulated Bioanalytical strategy. Qualifications Education:  A Bachelor's Degree in Biology, Biochemistry, Molecular Biology, Virology,  Pharmaceutical Sciences, or a related area degree with a minimum of 14 years of relevant experience, OR a Master's Degree in Biology, Biochemistry, Molecular Biology, Virology, Pharmaceutical Sciences, or related area with a minimum of 10+years of experience, OR a Ph.D. in Biology, Biochemistry, Molecular Biology, Virology,  Pharmaceutical Sciences, or a related area with a minimum of 8 years of experience.   Required:  A minimum of 10 years of experience in PCR assay development and optimization including expertise in troubleshooting experimental design, assay development and data analysis. Strong technical expertise in regulated bioanalytical assay design, development and execution in support of antiviral, antibacterial, and/or vaccine discovery.    Advanced knowledge in molecular biology assays such as DNA gel electrophoresis, DNA and RNA isolation, Real-Time PCR, reverse transcriptase PCR, and sequencing with demonstrated ability to achieve results. Ability to understand and implement applicable regulations regarding the use of pathogens (e. g. virus, bacteria, fungi), human cell and tissue use, laboratory safety, health physics and chemical hazards in research. Proven ability to lead the development of new, innovative approaches including experience with new assay technology evaluation and shaping scientific strategy both at the platform and program level. Excellent communication, mentoring, influencing and leadership skills. Ability to share knowledge and mentor more junior-level scientists Established external scientific reputation (e.g. publication record, leadership in consortia, external presentations). Expertise in authoring and reviewing program development documents and regulatory submissions as well as experience interacting with Health Authorities.  Preferred: In-depth understanding of the development process and comprehensive knowledge of the principles and concepts of vaccine clinical testing.   Candidate must be trained in GLP requirements and must have experience working in a regulated laboratory environment generating data suitable for submission to regulatory agencies. Experience with immunoassay platforms such as MSD, Luminex, ELISA, AphaLISA is a plus. Experience in cell-based functional assays to monitor immunogenicity Familiar with liquid handlers and other automation platforms for sample preparation and assay process. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  HJ052018 Job: Biologics, Vaccines, Analytical Formulat Other Locations: Employee Status: Regular Travel: Yes, 5 % of the Time Number of Openings: 1 Shift (if applicable): Hazardous Materials: human clinical samples Company Trade Name: Merck
Merck West Point, PA, US
May 25, 2018
Requisition ID: QUA006619 Our Manufacturing division in Kenilworth, N.J., U.S.A. is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our Manufacturing division has codified its legacy for over a century. Our Manufacturing division’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Responsibilities: Position carries out a variety of activities covering the various shifts to support 24/7 operations becoming familiar with site processes, procedures, and policies assuring alignment with cGMPs (current Good Manufacturing Processes) and Health Authority regulations.  Conducts batch record reviews, audits, investigations, and helps with internal audits / external inspections.  Supports sampling requirements for several areas.  Performs quarantine functions and accountability reviews.  Supports special projects as assigned.  Follow cGMP and routinely makes decisions using cGMP/process knowledge.  Works with customers to resolve problems and to satisfy quality and production needs.  Performs regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance.  Follows site safety requirements.  Authors, reviews, and or approves data and documents such as methods, procedures, and protocols.  Completes assigned projects.  Performs all work in a timely manner and is an active member of 1 or more teams.  Tracks/reports metrics. Qualifications Minimum Requirements: Bachelor's degree in a Scientific discipline (biology, engineering, or other science) 2 years experience in pharmaceutical industry or quality assurance/control Must be willing to work a rotating shift including nights and weekends Preferred Experience and Skills:  Demonstrated verbal/written communication and decision making skills Experience with GMP/compliance requirements for food or pharmaceutical industry; technical writing skills; understanding of computer system SAP and Office products; basic statistical understanding Your role at our Manufacturing division is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Manufacturing division, we’re inventing for life. <?xml:namespace prefix = "o" />   If you need an accommodation for the application process please email us at staffingaadar@merck.com.    Search Firm Representatives Please Read Carefully:  Our Manufacturing division is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at our Manufacturing division via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our Manufacturing division.  No fee will be paid in the event the candidate is hired by our Manufacturing division as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Qual Assurance & Ops Generic Other Locations: Employee Status: Regular Travel: Number of Openings: 5 Shift (if applicable): Hazardous Materials: Company Trade Name: Merck
Merck Elkton, VA, US
May 25, 2018
Requisition ID: QUA007445 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.  I. GENERAL SUMMARY: The Quality System & Compliance Batch Record Associate Specialist is responsible for document review and release support functions that supports Durham VMF 101 formulation and filling facilities.  The Associate Batch Record Review Specialist must adhere to regulatory, global and site policies and procedures governing product release. II. GENERAL PROFILE:   Performs routine assignments in the entry level to a professional role Requires knowledge and exposure to cGMP and GDP Develops competence by performing applicable work assignments Uses existing procedures to solve routine or standard problems Receives instruction, guidance and direction from others Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives   III. BUSINESS EXPERTISE:   Applies general knowledge of company business developed through education or past experience Understands and applies regulatory/ compliance requirements relative to their role   IV. FUNCTIONAL EXPERTISE:   Basic conceptual knowledge and practices associated with Document Review and Product Disposition Review and approve Culture Media, Filled Product, and Process Simulation Batch Records Execute review of electronic Master Batch Records (eMBR’s) utilizing reduced content review of critical steps and parameters as applicable within established deadlines Review and approve records from supplemental manufacturing operations through RtReports and autoclave logs Provide Quality review and approval of fill product dilution models Work with Operations Technical Support Team, Specialists, and Coaches to resolve issues identified during document review Perform necessary SAP transactions to indicate task completion to support batch record review decisions Participate in process improvement or learning events, as guided or approved by Quality management Author, review, and approve SOPs Direct support of regulatory inspections and audits, as requested Other duties as requested by Management   V. PROBLEM SOLVING:   Uses existing procedures to solve routine or standard problems Applies limited judgment and discretion   VI. INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:   Responds to standard requests from clients and/or customers   VII. IMPACT:   Errors or lack of understanding of the job may cause delays in releasing material for use in Operations and to the end market Influence and Decision Making: Communicates information, asks questions and checks for understanding Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines   VIII. PROJECT MANAGEMENT:   Accountable for contribution to project team or sub-team   IX. RESOURCE MANAGEMENT:   Builds awareness of costs related to own work   X. PHYSICAL REQUIREMENTS:   Ability to sit, stand and move within work space for extended periods Ability to perform repetitive tasks  Ability to lift up to 40 pounds   XI. WORKING RELATIONSHIPS: Reports to Assoc. Dir, Quality Assurance Interacts with employees within own department Frequent interaction with employees from other departments Interacts with representatives from regulatory agencies Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.   Qualifications Education Minimum Requirement:   Bachelor’s Degree Required Experience and Skills:   Minimum 1 year of experience in the pharmaceutical industry. Preferred Experience and Skills:  Quality Control, Quality Assurance and/or cGMP experience Batch record review experience   Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. <?xml:namespace prefix = "o" />   If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com .    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  Job: Quality GMP Related Other Locations: Employee Status: Regular Travel: No Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: No Company Trade Name: Merck
Merck Durham, NC, US
May 25, 2018
Requisition ID: TEC001167 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.  As part of the Direct Materials-Supplier Management group, API and Drug Product Category team, the Senior Sourcing Specialist supports global strategic sourcing to ensure compliant and cost competitive supply of active pharmaceutical ingredients (APIs) for Merck/MSD Animal Health Manufacturing division. Under the guidance of Director, API Category, the Sr. Specialist plays an important role in the development & execution of sourcing strategies and acts as a primary relationship manager within the assigned set of suppliers responsible for overall supplier relationship management. Duties and Responsibilities: People leadership Expected to lead sourcing projects and influence peers, as appropriate, in the leadership of API projects for example, cross-functional team members on a sourcing project team.  Sourcing Excellence: Supports development, recommendation and implementation of API sourcing strategies and ensures alignment, compliance and delivery of business requirements/needs. As API sourcing lead, demonstrates excellence in executing sourcing management process and closely collaborates with Quality, Supply Chain, Technology and Compliance groups during each step of the process. Market Knowledge and Insight: Uses thorough market knowledge and data analysis to gain critical insights that drive the selection of API Sourcing strategies and continuous improvement activities.   Project Management : Leads API/Direct Materials sourcing projects (using an established sourcing management process) to establish sources of supply via market intelligence gathering and analysis, competitive sourcing events (RFIs, RFP/RFQs), costs analyses, strategic analyses, due diligence/compliance assessments, and contract negotiations. Provides commercial support during source change execution phase. Proactive Cost Management:  Leads development, negotiation, and implementation of cost savings projects and multi-year supply agreements. Supplier Relationship Managemen t:  Leads supplier relationship management in close collaboration with the business stakeholders (at same organizational level or one to two levels above and across manufacturing support functions such Supply Chain Management, Quality Assurance, Technology, Environmental Health and Safety, Finance, Regulatory Affairs, Legal). Compliance and Risk Management: Responsible for compliance and risk management with assigned set of external supplier base. Contract Negotiati on and Management: Responsible to create detailed pre-negotiation plans, to lead and participate any prolonged negotiation sessions with suppliers and to conduct post negotiations debriefs and follow through plans. Qualifications Education: Bachelor’s Degree or equivalent( preferably in Engineering, Science, or Business fields) Required: Minimum five (5) years of combined work experience in strategic sourcing, contract negotiations, business operations and finance - within Human health or Animal health industry. Excellent English speaking and writing skills. Demonstrated ability to work well with people from many different disciplines. Strategic sourcing experience within pharmaceutical industry (Direct Materials and/or APIs) and familiarity with regulatory requirements (cGMPs). Excellent interpersonal, communication, collaboration, negotiation, analytical, and project management skills. Preferred: Post graduate degree in business (MBA), Finance, Engineering or Technical fields. Experience working with suppliers in North America, Europe and Asia in the pharmaceutical industry. Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.    If you need an accommodation for the application process please email us at staffingaadar@merck.com.    Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.   Visa sponsorship is not available for this position.   For more information about personal rights under Equal Employment Opportunity, visit:                EEOC Poster              EEOC GINA Supplement  MMDBTJD, HJ042018 Job: Technical Procurement Other Locations: Rahway, NJ, US Employee Status: Regular Travel: Yes, 10 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck
Merck Madison, NJ, US