About this opportunity
Regeneron Pharmaceuticals, Inc. lists this Staff External Manufacturing Specialist (Drug Product) opportunity in town of east greenbush, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Role
Senior technical expert overseeing clinical drug product filling operations at CMO sites, accountable for technology transfer, batch management, and GMP compliance.
Responsibilities
lead end-to-end tech transfer, evaluate cleanroom design, approve critical documentation, mentor mid-level specialists, monitor active batches, investigate deviations, and ensure regulatory adherence for sterile filling and lyophilization processes.
Requirements
Bachelor's or higher in Pharmaceutical Sciences, Chemistry, or related field; 10+ years' experience in pharmaceutical/biopharmaceutical sterile drug manufacturing, with hands-on GMP sterile filling expertise, tech transfer, and CMO oversight.
Preferred
leadership in process validation, deviation investigations, and cross-functional collaboration skills.
High-Value
expertise in aseptic filling, lyophilization, CCI, GMP compliance, regulatory documentation (IND, BLA), and international travel (~25%).
Location
Rensselaer, NY; on-site with travel.
The role emphasizes technical mentorship, active batch oversight, and ensuring product integrity in a GMP environment.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.