H-1B Visa Process Development Engineer Jobs

INTRODUCTION

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 tradeoff 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 tradeoffs, and know when and how to escalate.
• You are willing to try, learn, and iterate to keep programs moving forward and partners aligned.

BASIC QUALIFICATIONS

This role requires a B.Sc., with 5+, 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.

COMPENSATION

• Salary Range (annually): $93,900.00 - $153,300.00

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. 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 the careers page.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.