Process Development Engineer II, Advanced Therapy Project Management (ATPM)
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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.
Requirements
- 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
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
Responsibilities
- 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
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
