Full Job Description
Process Development Engineer II, Advanced Therapy Project Management (ATPM)
We are seeking a Process Development Associate to join our Advanced Therapy Project Management (AT-PM) group within Product, Analytical, and Process Development Operations (PAPD Ops) in an on-site capacity. In this role, you will support project management, technology transfer, and business operations for Regeneron's Advanced Therapy Programs, helping drive successful development and tech transfer of advanced therapies (e.g., AAV, bioconjugates, and synthetic chemistry programs), while collaborating with internal partners and Contract Development & Manufacturing Organizations (CDMOs) to enable clear cross-functional ways of working and operational excellence.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: On-site in Tarrytown, NY
- Work model/flexibility: Onsite, full-time
What you'll do:
- Lead cross-functional tech transfer teams and independently own workstreams to establish production processes at CDMOs
- Drive readiness for manufacturing start-up by clarifying scope, securing inputs and approvals, tracking deliverables, and escalating risks with proposed mitigations
- Own communication strategy and operating cadence for assigned programs, providing concise, decision-ready status reporting to audiences ranging from core teams to senior stakeholders
- Build, maintain, and continuously improve integrated plans across development and transfer activities, facilitating scenario planning to protect key milestones
- Anticipate and address risks to manufacturing readiness, defining mitigation plans to support rigorous CDMO campaign execution
- Lead recurring and ad-hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned
- Lead continuous improvement initiatives to mature AT-PM ways of working
- Partner with procurement, finance, legal, and internal stakeholders to support CDMO engagement, including RFPs, scope alignment, and contracting coordination
This role might be for you if:
- You take initiative, reliably follow through, and thrive in non-structured environments, navigating ambiguity and changing priorities with a strategic, action-oriented mindset
- You enjoy and excel at problem solving, breaking down complex technical and operational challenges into well-thought-out plans
- You like building structure and scalable frameworks that help cross-functional teams execute efficiently
- You proactively identify risks and roadblocks, communicate tradeoffs, and know when and how to escalate
- You're willing to try, learn, and iterate to keep programs moving forward and partners aligned
This role requires:
- B.Sc. in Biochemistry, Chemical/Biochemical Engineering, or a related field, with 6-8+ years of experience or a MS w/3-6+, including demonstrated ownership of cross-functional deliverables
- A strong customer-service mindset
- Ability to independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes
Preferred / nice-to-haves:
- Experience supporting CMC development and/or technology transfer to CDMOs (e.g., process development, analytics, documentation readiness)
- Experience or knowledge of bioconjugation, gene therapy/AAV, or
#pmpd
Salary Range (annually)
$93,900.00 - $153,300.00
