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

Initial Therapeutics, Inc.; Village of Tarrytown (NY); On-site; USD 93,900 - 153,300; Full time

Benefits offered by this job

Health and wellness programs

401(k) company match

Paid time off

Annual bonuses

Job summary

Regeneron in Tarrytown, NY is seeking a Process Development Engineer II to manage project operations for advanced therapy programs. The role involves leading cross-functional teams to ensure readiness for manufacturing and improving integrated planning. Candidates should hold a B.Sc. with 5+ years or M.Sc. with 3+ years in biochemistry or a related field. Benefits include health programs, a 401(k) match, and annual bonuses. Salary range: $93,900 - $153,300.

Qualifications

• 5+ years of experience with a B.Sc. or 3+ years with an M.Sc. in a relevant field.
• Experience in process development and technology transfer to CDMOs preferred.
• Strong customer-service mindset essential.

Responsibilities

• Lead cross‑functional tech transfer teams and establish production processes.
• Own communication strategy and status reporting.
• Build and maintain integrated plans across development activities.
• Define and execute mitigation plans for manufacturing readiness.
• Lead technical forums and continuous improvement initiatives.

Skills

Cross-functional team leadership

Technical problem solving

Process development

Risk management

Customer service mindset

Education

B.Sc. in biochemistry/chemical/biochemical engineering

Job description

Regeneron, located in Tarrytown, NY, is seeking a Process Development Engineer II to support project management, technology transfer, and business operations for Regeneron Advanced Therapy Programs. This representative will work in the Advanced Therapy Project Management (AT-PM) group within Product, Analytical, and Process Development Operations (PAPD Ops) to help drive successful development and tech transfer of advanced therapies (e.g., AAV, bioconjugates, and synthetic chemistry programs) by enabling clear cross‑functional ways of working, disciplined planning, and operational excellence with our internal partners and Contract Development & Manufacturing Organizations (CDMOs).

A Typical Day in This Role Might Look Like

• 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 (e.g., core team meetings, technical forums, and 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).

This Role Might Be For You If

• You take initiative, reliably follow through, and thrive in non‑structured environments, bringing energy, a strategic mindset, and an action‑oriented approach while navigating ambiguity and changing priorities.
• You enjoy and excel at problem solving and can break down complex technical and operational challenges, propose well‑thought‑out plans, and drive decisions.
• You like building structure and scalable frameworks that help cross‑functional teams execute efficiently and with the right balance of rigor and flexibility.
• You proactively identify risks/roadblocks, communicate trade‑offs, and know when and how to elevate issues.
• You are willing to try, learn, and iterate to keep programs moving forward and partners aligned.

This role requires a B.Sc., with 5+ years, or M.Sc. with 3+ years of biochemistry/chemical/biochemical engineering or a related field, including demonstrated ownership of cross‑functional deliverables. A strong customer‑service mindset is essential. The ideal candidate can independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes. Experience supporting CMC development and/or technology transfer to CDMOs (e.g., 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.

If applicable, candidates may include GPA on their resume.

In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.

Salary Range (annually)

$93,900.00 - $153,300.00