Scientist – Formulation Process Development Full-time

Scientist

Regeneron's Formulation Development Group (FDG) Process Development Team is seeking a Scientist to support drug product process development studies for biologics, including traditional monoclonal antibody (mAb) and non-traditional modalities (e.g. AAV, antibody tethered ligand, etc.). The candidate will work closely with FDG leads and scientists to ensure robust process development and seamless technology transfer to various manufacturing sites and to provide technical support towards GMP manufacturing, validation campaigns, and post-launch activities.

A Typical Day In The Role Might Look Like:

• Perform gap and risk assessment for drug product (e.g. manufacturing process, scale, contact parts, etc.) to inform requisite process development studies.
• Plan, design, and execute drug product process development studies for various biologics to ensure robust characterization of different unit operations (freeze/thaw, lyophilization, mixing, filtration, filling, etc.) across a number of fill sites.
• Assist in developing small-scale models to effectively mimic manufacturing unit operations and support technology transfer to manufacturing teams.
• Support in-house drug product toxicological lot manufacturing campaigns as needed.
• Work closely with FDG leads/scientists to ensure seamless progression of multiple late-stage process-related activities.
• Prepare, review, and edit technical reports.
• Bring in new ideas from literature and present work at group, department, and cross-functional meetings with a goal to improve efficiencies (e.g. in-silico modeling approaches, process analytics and related tools).
• Demonstrate strong and proactive problem-solving skills via critical thinking and effective communication.
• Manage process development equipment installation, operation, maintenance, calibration, and repairs.

This Job Might Be For You If You Have:

• The ability to work effectively independently as well as within a team environment.
• Capacity to multitask and quickly adapt to changes in priorities, as needed.
• Strong initiative and drive to complete challenging tasks and learn new technologies.

This position requires a BS degree in Biomedical or Chemical Engineering, Pharmaceutical Sciences, or related field with at least 10+ years of relevant industry experience or a MS degree with 8+ years of relevant industry experience. Experience with drug product development and characterization (formulation and process) required. Experience with lyophilization is desired. Hands-on experience with analytical instruments used for biologics including HPLC-based chromatographic techniques (icIEF, SEC, IEX), biophysical methods (DLS, DSC, and UV-Vis), particle characterization methods (MFI and HIAC) required. Other quantification methods (ddPCR, ELLA, mass photometry) preferred. Basic understanding of common protein degradation pathways and biophysics required. Experience with statistical software (JMP) to perform design of experiments and statistical analyses preferred.