Senior External DP Filling & Tech Transfer Lead

BioSpace; Town of East Greenbush (NY); On-site; USD 108,000 - 176,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Staff External Manufacturing Specialist to act as the technical and operational authority for clinical drug product (DP) filling at CMO sites, owning tech transfer end-to-end and driving batch disposition. You will serve as a GMP decision-maker and mentor mid-level EM specialists while collaborating with Quality, Regulatory, and Supply Chain teams.

The role requires extensive experience in sterile DP filling, CMO oversight, tech transfer leadership,

Qualifications

• Bachelor’s degree or advanced degree with 10+ years in pharmaceutical/biopharmaceutical DP manufacturing and CMO oversight.
• Hands-on sterile drug product filling operations in GMP environments.
• Experience leading tech transfer to CMO sites, including MBR/TRD approval, PPQ, and process validation.
• Experience leading deviation investigations and CAPA development for sterile filling.
• Ability to mentor technical staff and provide guidance in a team/lead capacity.
• Strong analytical, communication, and cross-functional collaboration skills; ability to influence in ambiguous situations.

Responsibilities

• Apply deep technical knowledge of aseptic filling unit operations including sterilizing-grade filters, filling, stoppering, capping and lyophilization development and scale-up.
• Interpret EM data, airborne particulates, and APS outcomes; assess implications for batch disposition.
• Partner with DP MSAT to apply lessons across the network regarding CCI, APS, filling operations, and CMO performance.
• Assess cleanroom design and equipment relative to contamination control requirements.
• Support E&L risk assessments for materials and container closure systems.
• Own end-to-end tech transfer to CMO filling sites; conduct gap/risk assessments and readiness.
• Approve TRD, MBR, validation reports and summary reports.
• Liaise between Quality Control, QA, Supply Chain, Regulatory, Legal, Sourcing and contract manufacturers.
• Serve as technical resource for mid-level EM Specialists; guide aseptic filling operations and deviation handling.
• Lead sub-teams on continuous improvement, filling upgrades, and CMO performance management.
• Lead deviation investigations and CAPA closure; assess impact on batches and filings.
• Track cycle times, yield trends, and rejection rates; drive improvements with CMO.
• Ensure product integrity and cGMP compliance at external manufacturers.
• Serve as GMP decision-maker for external DP filling; apply FDA/EU/USP/EP/JP requirements.
• Coordinate post-approval change strategies with Regulatory Affairs.
• Review CMC sections of regulatory submissions related to DP manufacturing and filling.
• Support GMP audits of CMO sites and identify compliance gaps.

Skills

Pharmaceutical DP manufacturing

Sterile filling operations

CMO oversight

Tech transfer leadership

GMP compliance

Mentorship

Analytical & cross-functional collab

Education

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

Job description

Regeneron Pharmaceuticals is seeking a Staff External Manufacturing Specialist to act as the technical and operational authority for clinical drug product (DP) filling at CMO sites, owning tech transfer end-to-end and driving batch disposition. You will serve as a GMP decision-maker and mentor mid-level EM specialists while collaborating with Quality, Regulatory, and Supply Chain teams.

The role requires extensive experience in sterile DP filling, CMO oversight, tech transfer leadership,