Process Development Engineer II: Advanced Therapy Program Lead

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Equity awards

401(k) company match

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc. (USA) is seeking a senior professional to lead cross-functional tech transfer teams and own end-to-end product transfer activities at CDMOs.

You will drive readiness for manufacturing startup, manage scope, inputs, approvals, and risk mitigation, and report status to senior stakeholders. The role emphasizes robust program execution and cross-functional collaboration across development and transfer activities.

Qualifications

• B.Sc. with 5+ years or M.Sc. with 3+ years in biochemistry, chemical/biochemical engineering or related field.
• Experience supporting CMC development and/or technology transfer to CDMOs (process development, analytics, documentation readiness) is preferred.
• Knowledge of bioconjugation, gene therapy/AAV, or related advanced therapy process development is a plus.

Responsibilities

• Lead cross-functional tech transfer teams and 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 with mitigations.
• Own communication strategy and reporting tailored to senior stakeholders and various audiences.
• Build and continuously improve integrated plans across development and transfer activities.
• Facilitate scenario planning and trade-off discussions to protect milestones and portfolio priorities.
• Define mitigation plans and ensure teams execute with rigor for CDMO campaigns.
• Lead forums to drive timely decisions, resolve issues, and capture lessons learned.

Skills

Cross-functional leadership

Problem solving

Strategic thinking

Communication

Adaptability

Education

B.S. in biochemistry/related field

M.S. in biochemistry/related field

Job description

Regeneron Pharmaceuticals, Inc. (USA) is seeking a senior professional to lead cross-functional tech transfer teams and own end-to-end product transfer activities at CDMOs.

You will drive readiness for manufacturing startup, manage scope, inputs, approvals, and risk mitigation, and report status to senior stakeholders. The role emphasizes robust program execution and cross-functional collaboration across development and transfer activities.