Process Development Engineer II, Advanced Therapy Project Management (ATPM)

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Presencial; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity awards

401(k) company match

Health and wellness programs

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Cross-functional leadership

Problem solving

Strategic thinking

Communication

Adaptability

Educación

B.S. in biochemistry/related field

M.S. in biochemistry/related field

Descripción del empleo

Responsibilities

Lead cross‑functional tech transfer teams and independently 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/issues with proposed mitigations. Own communication strategy and operating cadence for assigned programs (core team meetings, technical forums, stakeholder updates). Provide concise, decision‑ready status reporting (scope, timeline, cost, risk) tailored to different audiences, including senior stakeholders. Build, maintain, and continuously improve integrated plans across development and transfer activities. Facilitate scenario planning and trade‑off discussions to protect key milestones and support portfolio‑level prioritization. Anticipate and address risks to manufacturing readiness related to process. Define mitigation plans and help ensure teams execute with rigor expected for successful CDMO campaign execution. Lead recurring and ad‑hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned. Translate learnings into tools to improve repeatability across modalities and CDMOs. 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, and invoice tracking).

Candidate Profile

Take initiative, reliably follow through, thrive in non‑structured environments, bring energy, a strategic mindset, and an action‑oriented approach while navigating ambiguity and changing priorities. Excel at problem solving, break down complex technical and operational challenges, propose well‑thought‑out plans, and drive decisions. Build structure and scalable frameworks that help cross‑functional teams execute efficiently with the right balance of rigor and flexibility. Proactively identify risks/roadblocks, communicate trade‑offs, and know when and how to escalate. Willing to try, learn, and iterate.

Qualifications

B.Sc. with 5+ years or M.Sc. with 3+ years in biochemistry, chemical/biochemical engineering or related field, including demonstrated ownership of cross‑functional deliverables. Strong customer‑service mindset. Experience supporting CMC development and/or technology transfer to CDMOs (process development, analytics, documentation readiness) is preferred. Prior experience or knowledge of bioconjugation, gene therapy/AAV, or related advanced therapy process development is a plus.

EEO Statement & Benefits

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits.