Manager, Formulations Development

Our Formulation Development Group (FDG) is seeking a highly motivated Manager for the drug product compatibility/in-use stability team. The Manager is responsible for designing and executing IV compatibility/in-use stability and microbial challenge studies to support clinical and commercial drug product dosing for various therapeutic modalities such as monoclonal antibodies, bispecific antibodies, proteins, ADCs, and AAVs.

• Collaborates with the analytical and formulation teams within the department cohesively to prioritize, schedule, and plan compatibility/in-use stability studies.
• Develops fit-for-purpose analytical methods to support formulation stability, compatibility testing and product characterization.
• Authors study protocols and technical documents for internal use and to support regulatory filings.
• Managing material, equipment, and lab for compatibility/in-use stability team.
• Support research and new technical development in the area of compatibility/in-use stability to expand the capabilities of the group.
• Designs formulation development and stability studies supporting antibody and related drug product development in various phases.
• Collaborates with clinical logistics and development groups, and serves as an SME to provide knowledge and expertise in clinical dose preparation and administration.
• Presents work at group, departmental, and cross functional meetings.

You have a PhD with 2+ years of experience, or a MS degree with 7+ years experience, ideally with a degree in pharmaceutical sciences, chemistry, analytical chemistry, biochemistry, or a related field with relevant biological drug product formulation or analytical development from biopharmaceutical industry

• Hands-on experience with IV admixture compatibility/in-use stability and/or pharmacy manual.
• Experience and trouble-shooting proficiency with column chromatographic (HPLC/UPLC) and subvisible particulate analysis are required.
• Excellent communication skills, with the ability to work in a fast-paced collaborative team environment.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.