Staff External Manufacturing Specialist (Clinical Drug Product)
Regeneron
August 22, 2026
On-site
East Greenbush, NY
Operations
Staff External Manufacturing Specialist — technical and operational authority for clinical contract drug product (DP) filling at CMO and business partner sites.
Responsibilities
- Provide deep technical expertise in aseptic filling operations: sterile filtration, filling (time-pressure, peristaltic, rotary piston), stoppering, capping, and lyophilization cycle development/scale-up.
- Interpret EM, airborne particulates, and media fill (APS) outcomes to support batch disposition and process adequacy.
- Partner with DP MSAT on lessons learned across the network (CCI, APS, filling operations, CMO assessments).
- Assess cleanroom/equipment suitability (ISO 5/Grade A, Grade B/C support) for contamination control.
- Support extractables/leachables (E&L) risk assessments for product-contact materials and container closure selection.
- Own end-to-end tech transfer to CMO filling sites (gap assessments, risk evaluations, readiness, engineering runs).
- Approve TRD, MBR, validation reports, and summary reports.
- Oversee tech transfer, qualification, and validation of isolator/RABS, filling systems, lyophilizers, and component prep equipment.
- Coordinate/oversee DP manufacturing at CMO per tech transfer and clinical operations.
- Liaise cross-functionally and with contract manufacturers/business partners.
- Provide technical mentorship to EM specialists (aseptic filling guidance, batch record review, deviation management, CMO oversight).
- Lead continuous improvement and filling technology upgrades; surface risks and shape external manufacturing strategy.
- Lead active batch management: track filling status, in-process results, and lot disposition milestones; monitor in-process data; lead deviation investigations and CAPA closure; analyze cycle times/yield/reject trends; drive drift detection and improvements.
- Serve as key GMP decision-maker (FDA 21 CFR, EU GMP Annex 1, USP/EP/JP).
- Evaluate regulatory impact of CMO change controls; coordinate post-approval change strategies; review CMC sections of IND/BLA/NDA/MAA related to DP filling.
- Support GMP audits; identify compliance gaps and assess risk.
Qualifications / Skills (Required)
- Bachelor’s or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related field; 10+ years in pharmaceutical/biopharmaceutical DP manufacturing with significant sterile filling and CMO oversight.
- Hands-on sterile drug product filling experience (aseptic filling, lyophilization, CCI, inspection) in GMP environment.
- Demonstrated tech transfer leadership/execution to CMO sites (MBR/TRD approval, PPQ, process validation).
- Experience leading deviation investigations and CAPA for sterile filling.
- Demonstrated ability to mentor/develop technical staff.
- Strong analytical, communication, and cross-functional collaboration skills; ability to influence and decide in ambiguous situations.
- Ability to travel domestically/internationally up to 25%+.
Application
- Apply now.
Responsibilities
- Provide deep technical expertise in aseptic filling operations: sterile filtration, filling (time-pressure, peristaltic, rotary piston), stoppering, capping, and lyophilization cycle development/scale-up.
- Interpret EM, airborne particulates, and media fill (APS) outcomes to support batch disposition and process adequacy.
- Partner with DP MSAT on lessons learned across the network (CCI, APS, filling operations, CMO assessments).
- Assess cleanroom/equipment suitability (ISO 5/Grade A, Grade B/C support) for contamination control.
- Support extractables/leachables (E&L) risk assessments for product-contact materials and container closure selection.
- Own end-to-end tech transfer to CMO filling sites (gap assessments, risk evaluations, readiness, engineering runs).
- Approve TRD, MBR, validation reports, and summary reports.
- Oversee tech transfer, qualification, and validation of isolator/RABS, filling systems, lyophilizers, and component prep equipment.
- Coordinate/oversee DP manufacturing at CMO per tech transfer and clinical operations.
- Liaise cross-functionally and with contract manufacturers/business partners.
- Provide technical mentorship to EM specialists (aseptic filling guidance, batch record review, deviation management, CMO oversight).
- Lead continuous improvement and filling technology upgrades; surface risks and shape external manufacturing strategy.
- Lead active batch management: track filling status, in-process results, and lot disposition milestones; monitor in-process data; lead deviation investigations and CAPA closure; analyze cycle times/yield/reject trends; drive drift detection and improvements.
- Serve as key GMP decision-maker (FDA 21 CFR, EU GMP Annex 1, USP/EP/JP).
- Evaluate regulatory impact of CMO change controls; coordinate post-approval change strategies; review CMC sections of IND/BLA/NDA/MAA related to DP filling.
- Support GMP audits; identify compliance gaps and assess risk.
Qualifications / Skills (Required)
- Bachelor’s or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related field; 10+ years in pharmaceutical/biopharmaceutical DP manufacturing with significant sterile filling and CMO oversight.
- Hands-on sterile drug product filling experience (aseptic filling, lyophilization, CCI, inspection) in GMP environment.
- Demonstrated tech transfer leadership/execution to CMO sites (MBR/TRD approval, PPQ, process validation).
- Experience leading deviation investigations and CAPA for sterile filling.
- Demonstrated ability to mentor/develop technical staff.
- Strong analytical, communication, and cross-functional collaboration skills; ability to influence and decide in ambiguous situations.
- Ability to travel domestically/internationally up to 25%+.
Application
- Apply now.