Process Development Lead, Advanced Therapy

BioSpace; Village of Tarrytown (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron is seeking a Process Development Associate to join the Advanced Therapy Project Management (AT-PM) group within PAPD Ops. This onsite, full-time role supports project management, tech transfer, and business operations for advanced therapy programs, collaborating with CDMOs to enable cross-functional, milestone-driven development and transfer of programs such as AAV and bioconjugates.

The role emphasizes ownership of workstreams, risk mitigation, and clear communications to senior

Qualifications

• B.Sc. in Biochemistry, Chemical/Biochemical Engineering, or a related field with 6-8+ years of experience or an MS w/3-6+ years.
• Strong customer-service mindset.
• Ability to independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes.

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.

Skills

Cross-functional collaboration

Project management

Problem solving

Communication

Education

B.Sc. in Biochemistry/ Chemical/Biochemical Engineering or related field

MS in relevant field

Job description

Regeneron is seeking a Process Development Associate to join the Advanced Therapy Project Management (AT-PM) group within PAPD Ops. This onsite, full-time role supports project management, tech transfer, and business operations for advanced therapy programs, collaborating with CDMOs to enable cross-functional, milestone-driven development and transfer of programs such as AAV and bioconjugates.

The role emphasizes ownership of workstreams, risk mitigation, and clear communications to senior