Scientist, Formulation Development (Gene Therapy & Antibody)

Regeneron's Formulation Development Group is seeking a Scientist with a strong background in protein biochemistry or biophysics to support early to late-stage development for biologics including antibodies and other novel modalities, such as AAV and lipid nanoparticle-based gene therapy products. In this role, you will be responsible for characterizing the drug candidates and leading the formulation development to enable the preclinical and clinical development. You will also perform research on product characterization, new formulation, analytical technology development and implementation.

A Typical Day in the Role of Scientist May Include the Following:

• Design and execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support formulation and drug product development for early and late-stage development programs, may include antibodies, AAV or LNP.
• Develop and apply fit-for-purpose analytical, biochemical and biophysical methods to support candidate assessment, formulation development, manufacturing process development, and research stability testing.
• Conduct biochemical and biophysical characterization and pre-formulation studies to support evaluation of preclinical drug candidates.
• Provide technical support for development, technology transfer and clinical production of drug substance and drug product and collaborate with Analytical Development, Process Development, Preclinical/Clinical Development, Quality, External Manufacturing, and Program Management, etc.
• Lead or collaborate with other scientists in conducting research and developmental work, investigating, and solving development problems.
• Support tech transfer and outsourced activities at CDMOs and CROs as needed.
• Apply DoE and advanced statistical analysis tools to optimize study design and support manufacturing robustness and specification.
• Author and review formulation development sections of regulatory and technical documents, study reports, technology transfer documents, and manuscripts for publication.
• Participate in various cross-functional teams with regards to formulation and process development.

This Role Might Be for You If:

• You possess passion for science and innovation.
• You are motivated for making contributions in a team environment.
• You excel when working in a fast-paced environment.
• You have excellent interpersonal, oral, and written communication skills.

This role requires a Ph.D. in Biochemistry, Biophysics, Protein Chemistry, Pharmaceutical Science, or a related discipline with 0-2+ years of industry or academia working experience. Expertise in protein chemistry and protein characterization with keen analytical and problem-solving skills are a must. Experience with protein stability, structure or biophysics studies is highly desirable. Hands-on experience and troubleshooting proficiency with applying chromatography (SEC, IEX, RP, HIC) and/or biophysical techniques such as light scattering (DLS, MALS, SLS) and AUC for studying protein-protein interactions are desirable. Prior experience working with viral vectors, such as AAV, Lentivirus or other retrovirus vectors for gene and cell therapy products or LNP for drug delivery or vaccines is a plus.

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.