Senior External DP Filling & Tech Transfer Lead

Regeneron Pharmaceuticals, Inc (USA); United States; Presencial; USD 140.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity awards

Pension

401(k)

Health benefits

Paid time off

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Staff External Manufacturing Specialist to act as the technical and operational authority for clinical DP filling at CMO sites.

You will own end‑to‑end tech transfer, drive active batch management from pre‑production through lot disposition, and mentor mid‑level specialists while collaborating on compliance strategy. The role covers regulatory and GMP compliance, environmental monitoring interpretation, and continuous improvement across DP filling

Formación

• Bachelor’s or higher in Pharmaceutical Sciences, Chemical Engineering, Chemistry or related field.
• 10+ years in pharma/biopharma DP manufacturing with sterile filling and CMO oversight.
• Experience leading tech transfers to CMO sites including MBR/TRD approval, PPQ, and process validation.
• Strong analytical, communication and cross-functional collaboration skills.

Responsabilidades

• Apply deep technical knowledge of aseptic filling unit operations (sterile filtration, filling, stoppering, capping, lyophilization).
• Interpret EM data, ACP results, and media fill outcomes; assess batch disposition and process adequacy.
• Lead end‑to‑end tech transfer to CMO filling sites; approve TRD, MBR, validation reports.
• Oversee qualification/validation of filling lines and equipment (isolators, vials/syringe filling, lyophilizers).
• Coordinate DP manufacturing at CMO per project tech transfer and clinical operations.
• Liaise with Quality, Regulatory, Supply Chain, Legal and contract manufacturers.

Conocimientos

Mentorship

Analytical skills

Cross-functional collaboration

Communication

Educación

Bachelor’s degree or higher in Pharmaceutical Sciences / Chemical Engineering / Chemistry

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks a Staff External Manufacturing Specialist to act as the technical and operational authority for clinical DP filling at CMO sites.

You will own end‑to‑end tech transfer, drive active batch management from pre‑production through lot disposition, and mentor mid‑level specialists while collaborating on compliance strategy. The role covers regulatory and GMP compliance, environmental monitoring interpretation, and continuous improvement across DP filling