Principal Scientist, Drug Product Process Development (AAV, RNA, gene therapy

We are seeking a highly motivated Principal Scientist in the Process Development (PD) Team within the Formulation Development Group to support our genetics medicine.

The PD team supports programs across all stages of clinical development and provides technical leadership towards clinical & commercial drug product PD and technology transfer. We provide technical support towards GMP manufacturing, validation campaigns as well as post-launch activities for drug product.

You will lead a motivated team and support process development as a SME for programs, specifically comprised of gene therapy modalities (e.g., AAV, RNA-based etc.). Complex molecules as such tend to present unique process development challenges that requires additional and unique process and analytical characterization and optimization efforts.

You are crucial to advising and leading development of successful drug product processes for non-traditional modalities and ensure optimal product quality during manufacture.

A day as a Prinicpal Scientist may look like:

• Will lead and advise on capability, technology development & knowledge build with regards to process development and optimization within FDG for gene therapy modalities (AAV, RNA-based etc.).
• Be able to align process development capability for gene therapy programs with collaborators, including R&pD teams, Viral Production Core and Manufacturing team.
• Responsible for leading process development activities across programs, different stages of development, independently implementing and advising on at-scale and small-scale unit operations. Lead process characterization, optimization, scale-up and tech transfer, author development reports, support preclinical, clinical & PPQ phase related campaigns, facilitate risk assessments and technology transfers as well as review regulatory submissions.
• Will be accountable for development of scalable and robust processes (using engineering principles and methodologies) for vials and syringes( ex. drug substance freezing/thawing, compounding, mixing, filtration, filling, and lyophilization)
• Ensure strong strategic partnerships & communication with colleagues from Research groups, pre-clinical toxicology, Drug Product & Drug Substance Manufacturing (internal and external partners, CMOs), Project Management, Regulatory Sciences, and Quality
• Lead, review and complete project plans supported by strong scientific rationales and technical approaches & will be an effective communicator. Will be cognizant of project priorities (e.g., memos, reports) and timelines.
• Will participate in scientific conferences and forums to seek out, recognize and assesses new technologies to facilitate efficient and robust process development within FDG.

This role may be for you if:

• Strong project leadership & strong industry knowledge and experience in gene therapy drug product development & delivery technologies is required.
• Strong scientific leadership and management experience is required.
• Experience in general biologics product development including understanding of formulation, process and characterization fundamentals across various relevant modalities (e.g. mAbs, fusion proteins) and delivery forms is desired.
• Experience in developing relationships with external vendors, CROs, academic institutions and scientific leaders.
• Interpersonal and leadership skills and ability to influence others to achieve results.
• Experience mentoring junior scientists

To be considered you must have a PhD in Pharmaceutics, Biotechnology, Biomedical Engineering, Chemical Engineering, Biology or related field with a strong background in gene therapy-based drug product development and 3+ years industry experience. Or a BS/MS degree and 11+ years relevant expereince. Experience in AAVs, RNA therapeutics is desired.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$121,200.00 - $197,800.00