Process Development Engineer II, Advanced Therapy Project Management (ATPM)
Regeneron
August 21, 2026
On-site
Tarrytown, NY
Operations
Process Development Associate — Advanced Therapy Project Management (AT-PM) (On-site, Tarrytown, NY)
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; provide concise, decision-ready status reporting to core teams and senior stakeholders
- Build, maintain, and continuously improve integrated plans across development and transfer activities; facilitate scenario planning to protect milestones
- Anticipate and address risks to manufacturing readiness and define mitigation plans for 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 (RFPs, scope alignment, contracting coordination)
This Role Might Be For You If:
- You take initiative and thrive in non-structured environments, navigating ambiguity and changing priorities
- You excel at problem solving by breaking down complex technical/operational challenges into plans
- You build scalable frameworks to help cross-functional teams execute efficiently
- You proactively identify risks/roadblocks, communicate tradeoffs, and escalate appropriately
- You are willing to try, learn, and iterate to keep programs moving and partners aligned
This Role Requires:
- B.Sc. (Biochemistry, Chemical/Biochemical Engineering, or related) with 6–8+ years, or M.S. with 3–6+, including demonstrated ownership of cross-functional deliverables
- Strong customer-service mindset
- Ability to facilitate team collaboration, build/maintain integrated plans, and design/improve repeatable business processes
Preferred / Nice-to-haves:
- Experience supporting CMC development and/or technology transfer to CDMOs (process development, analytics, documentation readiness)
- Experience or knowledge of bioconjugation, gene therapy/AAV
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; provide concise, decision-ready status reporting to core teams and senior stakeholders
- Build, maintain, and continuously improve integrated plans across development and transfer activities; facilitate scenario planning to protect milestones
- Anticipate and address risks to manufacturing readiness and define mitigation plans for 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 (RFPs, scope alignment, contracting coordination)
This Role Might Be For You If:
- You take initiative and thrive in non-structured environments, navigating ambiguity and changing priorities
- You excel at problem solving by breaking down complex technical/operational challenges into plans
- You build scalable frameworks to help cross-functional teams execute efficiently
- You proactively identify risks/roadblocks, communicate tradeoffs, and escalate appropriately
- You are willing to try, learn, and iterate to keep programs moving and partners aligned
This Role Requires:
- B.Sc. (Biochemistry, Chemical/Biochemical Engineering, or related) with 6–8+ years, or M.S. with 3–6+, including demonstrated ownership of cross-functional deliverables
- Strong customer-service mindset
- Ability to facilitate team collaboration, build/maintain integrated plans, and design/improve repeatable business processes
Preferred / Nice-to-haves:
- Experience supporting CMC development and/or technology transfer to CDMOs (process development, analytics, documentation readiness)
- Experience or knowledge of bioconjugation, gene therapy/AAV