Scientist - Formulation Process Development

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. 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.

Requirements

• 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.

Benefits

• Health and wellness programs (including medical, dental, vision, life, and disability insurance)
• Fitness centers
• 401(k) company match
• Family support benefits
• Equity awards
• Annual bonuses
• Paid time off
• Paid leaves (e.g., military and parental leave)