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Process Development Engineer II, Advanced Therapy Project Management (ATPM)

External
Regeneron logoRegeneron · Tarrytown
ContractOn-site5d ago
DocumentationExcel
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Regeneron, located in Tarrytown, NY, is seeking a Process Development Engineer II to support project management, technology transfer, and business operations for Regeneron Advanced Therapy Programs. This representative will work in the Advanced Therapy Project Management (AT-PM) group within Product, Analytical, and Process Development Operations (PAPD Ops) to help drive successful development and tech transfer of advanced therapies (e.g., AAV, bioconjugates, and synthetic chemistry programs) by enabling clear cross-functional ways of working, disciplined planning, and operational excellence with our internal partners and Contract Development & Manufacturing Organizations (CDMOs). A Typical Day in This Role Might Look Like: Lead cross-functional tech transfer teams and independently own workstreams to establish production processes at CDMOs. Drive readiness for manufacturing start-up and execution by clarifying scope, securing inputs/approvals, tracking deliverables, and escalating risks/issues with proposed mitigations. Own communication strategy and operating cadence for assigned programs (e.g., core team meetings, technical forums, and stakeholder updates). Provide concise, decision-ready status reporting (scope/timeline/cost/risk) tailored to different audiences, including senior stakeholders. Build, maintain, and continuously improve integrated plans across development and transfer activities. Facilitate scenario planning and tradeoff discussions to protect key milestones and support portfolio-level prioritization. Anticipate and address risks to manufacturing readiness related to process. Define mitigation plans and help ensure teams execute with rigor expected for successful CDMO campaign execution. Lead recurring and ad-hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned. Translate learnings into tools to improve repeatability across modalities and CDMOs. Lead continuous improvement initiatives to mature AT-PM ways of working. Partner with procurement, finance, legal, and internal stakeholders to support CDMO engagement (RFPs, scope alignment, contracting coordination, and invoice tracking). This Role Might Be For You If: You take initiative, reliably follow through, and thrive in non-structured environments, bringing energy, a strategic mindset, and an action-oriented approach while navigating ambiguity and changing priorities. You enjoy and excel at problem solving and can break down complex technical and operational challenges, propose well-thought-out plans, and drive decisions. You like building structure and scalable frameworks that help cross-functional teams execute efficiently and with the right balance of rigor and flexibility. You proactively identify risks/roadblocks, communicate tradeoffs, and know when and how to escalate. You are willing to try, learn, and iterate to keep programs moving forward and partners aligned. This role requires a B.Sc., with 5+, or M.Sc. with 3+ years of biochemistry/ chemical/biochemical engineering or a related field, including demonstrated ownership of cross-functional deliverables. A strong customer-service mindset is essential. The ideal candidate can independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes. Experience supporting CMC development and/or technology transfer to CDMOs (e.g., process development, analytics, documentation readiness) is preferred. Prior experience or knowledge of bioconjugation, gene therapy/AAV, or related advanced therapy process development is a plus. If applicable, candidates may include GPA on their resume. #pmpd Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron o


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