18 jobs found in West Point, PA

Merck Job Description The West Point Technical Operations organization within the company's Manufacturing Division is responsible for providing technical support to vaccine manufacture through technical investigations, lifecycle-management driven process enhancements, and commercial vaccine expansions. We are seeking an experienced Associate Director, Engineering to join Technical Operations in West Point, PA. The candidate will have a primary role providing manufacturing process support to our company's portfolio of live virus vaccines. The candidate will collaborate with key stakeholders to design and analyze experiments to enhance production of these vaccines and to provide technical support to the manufacturing shop floor. The candidate will additionally serve as a resource for the broader vaccine manufacturing organization as a subject matter expert (SME). The ideal candidate will have a strong background in virology, host-cell interactions, cell biology,...

Merck Job Description The Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Associate Principal Scientist, Device System - Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept...

Merck Job Description The Senior Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept through commercialization and...

Merck Job Description We are seeking a visionary and transformative leader for the position of Director, Data Science, within our Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) department. This role is responsible for driving the overarching data science strategy for PDMB, leading a world-class team of data scientists, and pioneering the development and deployment of cutting-edge AI/ML innovations. The ideal candidate is a proven scientific and business leader with a "tri-lingual" ability to speak the languages of science, technology, and business strategy. You will be responsible for coaching, mentoring, and developing a high-performing team while forging critical partnerships with internal R&D functions and external academic and industry collaborators. This role is central to our mission, requiring you to identify needs and opportunities and deliver data science solutions that improve quality and efficiency, enable critical Go/NoGo decisions and...

Merck Job Description The West Point Technical Operations organization within the company's Manufacturing Division is responsible for providing technical support to vaccine manufacture through technical investigations, lifecycle-management driven process enhancements, and commercial vaccine expansions. We are seeking an experienced Associate Director, Engineering to join Technical Operations in West Point, PA. The candidate will have a primary role providing manufacturing process support to our company's portfolio of live virus vaccines. The candidate will collaborate with key stakeholders to design and analyze experiments to enhance production of these vaccines and to provide technical support to the manufacturing shop floor. The candidate will additionally serve as a resource for the broader vaccine manufacturing organization as a subject matter expert (SME). The ideal candidate will have a strong background in virology, host-cell interactions, cell biology,...

Merck Job Description The Senior Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept through commercialization and...

Merck Job Description We are seeking a visionary and transformative leader for the position of Director, Data Science, within our Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) department. This role is responsible for driving the overarching data science strategy for PDMB, leading a world-class team of data scientists, and pioneering the development and deployment of cutting-edge AI/ML innovations. The ideal candidate is a proven scientific and business leader with a "tri-lingual" ability to speak the languages of science, technology, and business strategy. You will be responsible for coaching, mentoring, and developing a high-performing team while forging critical partnerships with internal R&D functions and external academic and industry collaborators. This role is central to our mission, requiring you to identify needs and opportunities and deliver data science solutions that improve quality and efficiency, enable critical Go/NoGo decisions and...

Merck Job Description The Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Associate Principal Scientist, Device System - Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept...

Merck Job Description Job Description: Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Process Operations Specialist is responsible for leading and executing GMP bioreactor operations in support of clinical manufacturing campaigns, ensuring consistent execution of upstream processes and supporting integration with other process areas. The Specialist applies technical knowledge, problem solving and leadership skills to deliver high-quality, compliant biomanufacturing operations. Key Responsibilities: Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000L in stainless steel, glass, and...

Merck Job Description Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Senior Specialist, GMP Process Operations, serves as a technical expert and operational leader within the upstream bioreactor operations team. This role is hands-on, providing both direct process execution and leadership across multiple manufacturing campaigns. The Senior Specialist applies deep technical knowledge of bioreactor systems and GMP compliance to ensure successful production of clinical materials, effective technology transfer of new processes and continuous improvement of manufacturing operations. Key Responsibilities: Lead and execute GMP bioreactor operations...

Merck Job Description We are seeking a collaborative, self-motivated Senior Scientist to join the Drug Metabolism and Pharmacokinetics (DMPK) Group within the Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) organization at our Company's Research Laboratories in West Point, PA. The main goal of this position is to support the advancement of drug candidates through characterization of absorption, distribution, metabolism, and elimination (ADME) properties of therapeutics. Successful candidates will provide enzymology expertise and independently design and execute experiments utilizing in silico, in vitro, and in vivo methodologies to assess drug disposition and drugdrug interaction risk, and contribute to decisionmaking for lead discovery and development. The role requires strong laboratory execution, data analysis and documentation skills, the ability to work across interdisciplinary project teams, and the capacity to design novel approaches to solve complex...

Merck Job Description Within the Planning and Manufacturing Systems (PAMS) organization, the PAMS Project Manager will design, configure, validate, and support electronic batch records (EBRs) and manufacturing execution workflows using PAS-X and a new EBR system which is still in development, enabling compliant, efficient, and data-driven operations across GMP manufacturing. Based in the Bioprocess and Clinical Manufacturing Technology Department within the Biologics Pilot Plant (BPP) in West Point, PA, the Project Manager will own project planning, delivery and sustainment for MES/EBR (Manufacturing Execution System/Electronic Batch Record) initiatives. This role requires intense collaboration with Quality (QA/QC) and will serve as the primary interface between the BPP and the IT organization to ensure compliant, secure, and reliable system operations. The new EBR system will be deployed to support Clinical Bulk Manufacturing operations. Key Responsibilities: Lead...

Merck Job Description Senior Specialists in the Infectious Disease and Vaccines group in the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to enable drug-development decision-making from drug discovery through approval. Senior Specialists will work in collaborative teams and with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform the primary responsibilities of the role including: Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new drug and vaccine candidates Developing and executing pharmacokinetics and pharmacodynamics modelling approaches, such as noncompartmental analysis, population pharmacokinetic, exposure-response, quantitative system pharmacology, viral dynamics, model-based meta-analysis, and other model-based analyses Perform clinical trial...

Merck Job Description The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile. They will assess DDI risk using static mechanistic...

Merck Job Description Within the Planning and Manufacturing Systems (PAMS) organization, the PAMS Project Manager will design, configure, validate, and support electronic batch records (EBRs) and manufacturing execution workflows using PAS-X and a new EBR system which is still in development, enabling compliant, efficient, and data-driven operations across GMP manufacturing. Based in the Bioprocess and Clinical Manufacturing Technology Department within the Biologics Pilot Plant (BPP) in West Point, PA, the Project Manager will own project planning, delivery and sustainment for MES/EBR (Manufacturing Execution System/Electronic Batch Record) initiatives. This role requires intense collaboration with Quality (QA/QC) and will serve as the primary interface between the BPP and the IT organization to ensure compliant, secure, and reliable system operations. The new EBR system will be deployed to support Clinical Bulk Manufacturing operations. Key Responsibilities: Lead...

Merck Job Description The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile. They will assess DDI risk using static mechanistic...

Merck Job Description We are seeking a collaborative, self-motivated Senior Scientist to join the Drug Metabolism and Pharmacokinetics (DMPK) Group within the Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) organization at our Company's Research Laboratories in West Point, PA. The main goal of this position is to support the advancement of drug candidates through characterization of absorption, distribution, metabolism, and elimination (ADME) properties of therapeutics. Successful candidates will provide enzymology expertise and independently design and execute experiments utilizing in silico, in vitro, and in vivo methodologies to assess drug disposition and drugdrug interaction risk, and contribute to decisionmaking for lead discovery and development. The role requires strong laboratory execution, data analysis and documentation skills, the ability to work across interdisciplinary project teams, and the capacity to design novel approaches to solve complex...

Merck Job Description Senior Specialists in the Infectious Disease and Vaccines group in the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to enable drug-development decision-making from drug discovery through approval. Senior Specialists will work in collaborative teams and with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform the primary responsibilities of the role including: Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new drug and vaccine candidates Developing and executing pharmacokinetics and pharmacodynamics modelling approaches, such as noncompartmental analysis, population pharmacokinetic, exposure-response, quantitative system pharmacology, viral dynamics, model-based meta-analysis, and other model-based analyses Perform clinical trial...