Assoc Prin. Scientist, Engineering Position Available In Kennebec, Maine

Assoc Prin. Scientist, Engineering at Merck in Augusta, Maine, United States Job Description Job Description Associate Principal Scientist, Sterile Drug Product Commercialization As part of our Company’s Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites. The SDPC group is the division’s leader in sterile drug product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel vaccines, biologics, pharmaceutical products and combination products. The SDPC group supports the growing pipeline of diverse products and evolving technologies. We are seeking a highly motivated Associate Principal Scientist, Technical Transfer Leader to join our team in this role. This candidate will either be hybrid or remote, with a preference for hybrid. This role will focus on end-to-end technical transfer leadership for technology transfers of all sterile drug products in our pipeline, primarily in large molecules, to clinical and commercial manufacturing sites. This person will be accountable for directing technical transfer standard processes to drive excellence in the execution of our commercialization programs. Accountabilities and Responsibilities for this position include but are not limited to the following: Leading Technology Transfer Projects to ensure Right-First-Time, On-Time Delivery + Accountable for the overall drug product technology transfer (TT) activities providing end-to-end visibility on sending and receiving site deliverables for the process, analytical and facility readiness + Primary point of contact representing drug product technology teams to cross-functional stakeholders and senior leadership, and effectively communicates plans and escalations in a timely manner + Leads cross-functional, matrixed technology transfer team to achieve right first-time validation with line-of-sight to filing and licensure + Provides oversight to DP activities including process development, process characterization plan and execution, technology transfer control strategy, Process Performance Qualification (PPQ) readiness, execution, filing, launch and post-launch support + Influences and leads collaboration effectively diverse teams (cross-functionally, cross-culturally, and across internal / external sites) to align and drive TT results + Engages and supports the resolution of technical issues, regulatory authoring and filing activities + Supports Person In Plant (PIP) activities to provide oversight of manufacturing execution Planning / Governance + Accountable for the overall TT strategy and TT plan, including the detailed planning, oversight of schedules, gap and risk assessments, knowledge and data plans for the process, analytical and facility readiness + Responsible for the preparation and presentation of stage gate readiness and reviews to cross-functional stakeholders and senior leadership + Authors facility fit assessments and validation strategy documents, supports sending and receiving unit deliverables + Reviews and authors technology transfer documentation from sending site (control strategy, comparability strategy etc.), and receiving site (development and validation protocols, Batch Reports, campaign summary reports, PPQ reports, investigation reports etc.), authoring BLA/MAA sections + Ensures TT standards and workflows are applied throughout TT + Responsible for Data and Knowledge Management plans, accountable for knowledge sharing and After-Action Reviews with other TT teams + Works with program leadership teams to manage program escalations and works with New Product Introduction/Operations lead for business unit operations escalations Cross-functional relationships + Builds strong cross-divisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory-CMC, and Supply Chain, etc.) + Ensures that TT team is connected to the wider program teams and functional teams to ensure alignment with partners and stakeholders Project Management + Accountable to ensure TT project deliverables (metrics) are met and are on time, including regulatory filing and approval + Provides end-to-end project management of the TT Education Minimum Requirements + B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or + Master’s degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or + Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience Preferred Experience and Skills + Strong knowledge of product commercialization lifecycle and TT milestones, specifically in technical deliverables + Experienced in sterile drug product fill finish manufacturing practices + Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations + Experience in authoring and reviewing CMC regulatory documentation + Excellent interpersonal that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas + Excellent communication skills, verbal and written, project planning and presentation skills. + Effective communication style to ensure stakeholders and partners are informed of plans, status, risks and resolutions in timely manner + Strong decision-making skills with the ability to navigate ambiguous situations, leveraging strategic thinking and risk management rationale + Change agile with the ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans + Project management and activities management skills (dashboards, activity trackers) + Digital tool competency with OnePMO, MS Teams, Power BI, MSPO, Spotfire, SharePoint and other related systems This position may require travel up to 25% domestic and/or international travel; Must be able to travel for this position. Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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