45 process operator jobs found

Merck Job Description Location: Boston, MA Department: Biology-Discovery / Neuroscience Our Company's Neuroscience is recruiting a Principal Scientist in Boston/Cambridge, MA to develop and oversee implementation of biomarker discovery and translational strategies. We are seeking a highly motivated and experienced scientist to join our Neuroscience team in a role that will drive biomarker discovery and enable clinical translation by integrating cutting-edge data analytics, novel assay development, and cross-functional collaboration. The successful candidate will be an experienced Neuroscientist with expertise in drug discovery, novel biomarker discovery, and assay developmentacross diverse platforms. You will collaborate across multiple drug discovery teams and functional areas including Discovery, Translational Experimental Medicine, Translational Genome Analytics and Quantitative Pharmacometrics teams. You will develop experimental strategies that leverage in...

Biogen About This Role: As the Lead Deskside Support Analyst, you will be an integral part of the IT Deskside Services team, guiding all aspects of day-to-day incidents, tasks, and project delivery operations throughout the enterprise. This position requires you to help oversee onboarding support, equipment provisioning and deprovisioning, and provide deskside, labs, commercial, and VIP support. You will also manage onsite and offsite meetings and events, along with ServiceNow queue management. Serving as a technical mentor, you will offer training resources to internal and external team members, ensuring high customer satisfaction and smooth business operations. Additionally, you will document key deskside support processes, create training materials, and uphold support standards. Occasional travel may be required to provide support for external events, contributing to uninterrupted business operations and minimal escalations. What You'll Do: Serve as the one of the...

Biogen This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems. Collaborating closely with QC teams, Quality, Planning, Warehouse, Validation, and Manufacturing teams, you will help ensure that operations run smoothly. Your role may also involve assisting with GMP compliance activities, investigation writing, and continuous improvement initiatives. By working independently and...

Biogen About This Role Associate Director, Global Price & Access will help to develop and execute the global pricing, reimbursement and market access strategy for our future broader Nephrology portfolio. The Associate Director/Senior Manager, Global Price & Access (Pricing and Reimbursement) will be responsible for supporting the ongoing reimbursement/launch preparation in US, EU, and international markets. The individual will help to lead key global P&RS initiatives such as global pricing policy, pricing communications, value proposition and messages, detailed forecast assumptions, global price bands and launch sequence, support strategies with in-depth market research, environmental data & analogs. Additional focus will be to support LCM activities for nephrology, including providing input to new indication expansion business cases, Phase 3 trials, LTE and biomarker studies. Ability to collaborate with Cross-Functional colleagues, regional and US MAx...

Biogen About This Role The Fluid Biomarker group is seeking a highly motivated, experienced individual to join a dynamic team engaged in the implementation of biomarkers to support clinical therapeutic development. This role is required to oversee and support the development, implementation, and execution of biomarker strategies in support of programs in the Immunology portfolio. The successful candidate will have immunology expertise and a proven track record of strong leadership developing and delivering on biomarker strategies across all stages of drug development, with a particular focus on Phase 2 and beyond clinical development. Excellent strategic thinking, communication and collaboration skills are essential. What You'll Do In collaboration with other members of the biomarker team, develop and implement biomarker strategies for preclinical and clinical development programs. Provide guidance and direction to fluid members of the group focused on biomarker...

Biogen About This Role: We are seeking a Director of Advanced Analytics, Data Science & AI to spearhead efforts in generating and delivering data-driven insights that bolster a brand, therapeutic area, or cross-brand/enterprise initiatives, enhancing our innovative capabilities. Positioned at the heart of our strategic endeavors, this role involves influencing business partners, leading the execution and interpretation of AI/ML models, framing complex problems, and crafting compelling solutions. You will play a pivotal role in communicating clear and impactful data-driven insights across various teams. This dynamic and fast-paced position within a highly collaborative environment covers a broad range of strategic topics critical to our business success. To excel, you must possess an unwavering passion for data-driven problem solving, a robust background in data science and AI, and a track record of leading and developing high-performing teams that drive meaningful change...

Biogen About the Role: The Head of Portfolio and Project Management at the Biogen West Coast Hub (WCH) is a leadership role with strategic, enterprise-level responsibilities focusing on transformation and operational efficiency. This leader is accountable for shaping and executing portfolio strategy, driving an operational efficient PM organization, and ensuring operational excellence across clinical programs at the West Coast Hub (WCH). What You'll do: 1. Strategic Leadership & Portfolio Management Define and implement the WCH portfolio and project management strategy, aligning with enterprise objectives. Lead the Portfolio & Project Management function, influencing organizational direction and decision-making. Partner with WCH Chief of Staff and counterparts at Biogen HQ to maintain awareness of, and alignment with, corporate processes and initiatives. Lead the group in piloting and adopting WCH-specific versions of HQ processes and initiatives,...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

Biogen About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on nights (5:45 PM - 6 AM ET) Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including - Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Upstream / Cell Culture: Mammalian cell culture & harvest: Work in Shake flasks, WAVE bags,...

Biogen About this role The Senior Medical Manager is a part of the US Medical Nephrology team, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member of the US Medical Nephrology and reporting to the Nephrology Medical Director, the Senior Medical Manager will collaborate closely with Medical Operations to coordinate and execute the Nephrology key medical strategies and tactics. Biogen's priority is to continue to foster and enable a diverse and inclusive workforce - representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities - that reflects the communities where we operate and the patients who we serve. What You Will Do Be a credible/medical scientific expert who is accountable as the primary Nephrology medical representative and process driver that reviews and coordinates submissions for both the Commercial...

Biogen About This Role The Senior Manager, Insights & Analytics will play a critical role within the US Lupus team. You will be a proactive strategic thought partner for the US Brand team, responsible for driving actionable insights & deep understanding of the customer, overall market, and competitive landscape in both systemic and cutaneous lupus. This role plays a vital part in shaping the direction of the business and contributing to brand success. You will directly support the US Lupus brand team, focused on building foundational insights and building a go-to-market roadmap for one pipeline asset across multiple indications. You will provide critical insights for informed decisions, allowing for competitive positioning, and driving strategic initiatives based on an insights-driven approach. As a key partner to commercial and marketing leadership, you will help identify & address the most important business problems facing the franchise and help to develop...

Biogen About This Role: As the Director of Quality Control, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment, testing procedures. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain. What You'll Do: Lead the Pharma Site QC Operations organization - Management of...

Biogen About This Role: In the role of Decision Analytics Senior Manager, you will be a pivotal leader within Biogen's Decision and Quality Analytics Innovation (DQAI) group, which is part of our Development department. As a member of the DQAI team, your primary mission is to drive smarter decisions and measurable impact across our research, development, and medical initiatives. This position requires a blend of strategic acumen and technical proficiency, enabling you to translate complex data into narratives that drive both operational and strategic outcomes. You will oversee strategic direction-setting for decision analytics frameworks, AI/ML-enabled innovations, and enterprise-wide program modeling practices. By partnering with cross-functional R&D teams and external collaborators, you'll play a critical role in shaping enterprise decision science maturity and advancing our analytic capabilities. What You'll Do: Lead end-to-end program modeling efforts for...

Biogen About This Role The Medical Research Contract Lead is the primary budget reviewer and contract manager for all research approved by the Biogen Medical Research Review Committee - this includes a portfolio of investigator sponsored and Biogen-sponsored phase 4 studies. Working closely with Legal, the Contract Lead is the main point of contact for teams conducting medical research globally, investigator sites, CRO staff, and Medical's Global and Affiliate Legal partners for all things related to budget and contracting from proposed budget assessments to execution of a study agreement. In addition, using the knowledge gained as contracts are completed, they work with Legal to identify areas of improvement in the contracting process, templates, and guidance. The Contract Lead also manages training on budgeting and contracting topics to all stakeholders. What You'll Do Assess study budgets for fair market value alignment Populate contract templates for...

Biogen About This Role: As the Global Training Compliance - Corporate Quality, you will be at the forefront of ensuring the quality and compliance oversight and execution of our global GxP Training process as member of the Corporate Quality team. This pivotal role involves acting as Quality Unit for the Global GxP Training process and the Business System Owner for the Veeva Vault Training system, ensuring its alignment with both regulatory standards and organizational objectives. You will spearhead the design, implementation, and ongoing improvement of this system, collaborating with cross-functional teams to maintain high compliance standards. By monitoring metrics and KPIs, and escalating issues to senior leadership, when necessary, you ensure that our training process is not only efficient but also enhances our global operations. Your insights will be invaluable during audits and inspections, as you represent the process to regulatory bodies. Embedded within a global...

Biogen About This Role The Governance, Risk & Control (GRC) Grants Team is dedicated to executing on Biogen's global grants and giving strategy, which aims to catalyze scientific innovation, addressing unmet patient needs and advance medical and disease education. The Global Grants Manager, Governance, Risk & Control, is critical to the department's success as they act as the primary support for the Senior Manager, Governance, Risk & Control for the Global Grants portfolio. Additionally, they will manage the Grants Customer Service for both internal and external stakeholders. What You'll Do Assist with the assigned portfolio of grants including request review, organization qualification, due diligence, decision communications, reconciliations, and refunds. Responsible for validating and reconciling all completed grants by confirming that funds were used appropriately, reviewing any material changes to the funded activities, and identifying any unused...

Biogen About This Role: As the Managed Service Lead for Cybersecurity, you will be an integral member of the Access Automation leadership team, reporting directly to the Head of Access Automation. In this senior role, you will lead a team of approximately 20-25 Managed Service Provider (MSP) resources, driving operational excellence in Identity and Access Management (IAM). Access Automation serves as a foundational component of Biogen's application security and GXP/Quality compliance initiatives. Your leadership will be pivotal in delivering Resilience, Simplification, and Scale through continuous service improvements that impact all Biogen colleagues and numerous external stakeholders. You must bring a sophisticated approach to managing complex enterprise initiatives and stakeholder interactions, with a keen focus on problem-solving, resource management, quality control, and risk management. Your role will also involve enhancing performance metrics by streamlining ad hoc...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...