Staff External Manufacturing Specialist (Drug Product)
Regeneron · Tech Valley
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Staff External Manufacturing Specialist role leading clinical drug product filling operations at contract manufacturing sites. Responsible for technology transfer, batch management, GMP compliance, and technical mentorship across external manufacturing partners.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-17). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related field
- 10+ years pharmaceutical/biopharmaceutical drug product manufacturing experience
- Hands-on sterile filling operations expertise (aseptic filling, lyophilization, inspection)
- Demonstrated technology transfer leadership for drug product filling process scale-up
- Experience leading deviation investigations and CAPA closure in sterile operations
- Proven ability to mentor technical staff and lead cross-functional teams
- Willingness to travel domestically and internationally up to 25%+
What you'll be doing
- Lead end-to-end technology transfer operations to CMO filling sites, including gap assessments, validation, and qualification
- Serve as primary technical contact for active clinical batches at external sites; monitor in-process data and drive lot disposition
- Interpret environmental monitoring, media fill, and particulate data to assess batch implications and process adequacy
- Lead deviation investigations and CAPA closure for filling-related events; track yield, cycle time, and reject rate trends
- Mentor mid-level specialists on aseptic filling operations, GMP regulations, and CMO oversight; provide technical guidance on batch records and data interpretation
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.