Principal Scientist, Gene Therapy Bioassay Development

Regeneron Genetic Medicines (RGM) Bioassay group seeks a highly motivated and hard-working Principal Scientist to join our team. In this role you will focus on the development/qualification/transfer of potency assays and sample testing to support gene therapy programs. You will collaborate across Regeneron teams in Research, Preclinical, Process Sciences, Quality Control and CRO/CDMO to support assay transfer to a GMP environment and IND/BLA filings.

A Typical Day Might Include the Following But Not Be Limited to:

• Develop de-novo, optimize/qualify potency assays (expression/function) for transfer to GMP environment
• Participate in troubleshooting technical and procedural issues
• Lead, guide, and work with other Scientists and Research Associates in conducting sample testing in potency assays to support multi-functional teams
• Communicate/coordinate activities and priorities with relevant groups
• Prepare and present data in cross-functional meetings and contribute in technical writing for IND, post-IND and BLA reports
• Stays ahead of technological/scientific developments and cGxP requirements in gene therapy and biologics space.

This Role May Be For You If You Have:

• Proven understanding and statistical skills for interpretation and analysis of potency data in context of broader process and product development
• Knowledge of cGxP requirements in gene therapy and biologics space
• Teamwork and problem solving in a fast-paced environment

This role requires a Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences or a related field and 0-5 postdoctoral experience, or a MS degree with 5+ year experience or a BS degree 7+ of relevant experience. In-depth knowledge and hand-on experience in techniques applied in the field of gene therapy to quantify expression/binding of target of interest and reflect its Mechanism of Action via ddPCR, RT-PCR, ELISA, MSD, WB, flow-cytometry, enzymatic and cell-based reporter assays, AAV and/or lentivirus transduction, cell-engineering (transfection/CRISPR), etc is a plus. Knowledge of cGxP requirements in gene therapy and biologics space is a plus. Excellent verbal/written communication and organizational skills and a track record of scientific accomplishments and publications

 

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