Senior External DP Filling & Tech Transfer Lead

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); Presencial; USD 108.000 - 176.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Staff External Manufacturing Specialist to lead tech transfer of DP filling to CMOs, manage batch disposition, and ensure GMP compliance across sites.

You will mentor mid-level EM specialists and collaborate with QA, Regulatory, and Sourcing to drive performance. You bring 10+ years in sterile DP manufacturing, strong leadership, and proven ability to guide cross-functional teams through complex tech transfers, deviations, CAPAs, and

Formación

• 10+ years in pharmaceutical/biopharmaceutical DP manufacturing.
• Experience with sterile filling operations (aseptic filling, lyophilization).
• Proven track record in tech transfer to CMO sites and MBR/TRD approval.

Responsabilidades

• Own end-to-end tech transfer of DP filling to CMO sites.
• Drive active batch management from pre-production through lot disposition.
• Lead deviation investigations and CAPA closure.
• Mentor mid-level External Manufacturing Specialists.
• Collaborate with QA, Regulatory, Supply Chain and Legal.
• Support GMP audits of CMO sites and regulatory submissions.

Conocimientos

Aseptic filling

Tech transfer leadership

GMP compliance

Batch management

cross-functional collaboration

Mentorship

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Staff External Manufacturing Specialist to lead tech transfer of DP filling to CMOs, manage batch disposition, and ensure GMP compliance across sites.

You will mentor mid-level EM specialists and collaborate with QA, Regulatory, and Sourcing to drive performance. You bring 10+ years in sterile DP manufacturing, strong leadership, and proven ability to guide cross-functional teams through complex tech transfers, deviations, CAPAs, and