Build our future together:
We are currently looking to fill a Staff External Manufacturing Specialist as the technical and operational authority for clinical contract drug product (DP) filling operations at CMO and business partner sites. Owns the tech transfer process end-to-end, drives active batch management from pre-production through lot disposition, and is a key GMP decision-maker. Provides technical mentorship and leadership to mid-level specialists, and collaborates with management on compliance strategy and CMO performance in the clinical operations space.
When & where:
Location: East Greenbush, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Travel requirement: 25% international and domestic
Discover your role:
Apply deep technical knowledge of aseptic filling unit operations: sterile filtration (bioburden reduction and sterilizing-grade filters), filling (time-pressure, peristaltic, rotary piston), stoppering, capping, and lyophilization cycle development and scale-up.
Interpret environmental monitoring (EM) data, airborne particulate results, and media fill (APS) outcomes; assess implications for batch disposition and process adequacy.
Partner with DP MSAT to evaluate and apply lessons learned across the network as it relates to CCI, APS, filling operations, CMO assessments, etc.
Assess cleanroom design and equipment suitability (ISO 5/Grade A filling zones, Grade B/C support areas) relative to product contamination control requirements.
Support extractables and leachables (E&L) risk assessments for product-contact materials and container closure system selection.
Own and lead end-to-end operations of tech transfer to CMO filling sites, gap assessments, risk evaluations and assessments, facility/equipment readiness, engineering run execution.
Approve Technical requirements document (TRD), Master Batch Records (MBR), validation reports, summary reports, etc
Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.
Serve as the primary technical resource for mid-level EM Specialists; provide hands-on guidance on aseptic filling operations, batch record review, deviation management, and CMO oversight.
Lead sub-teams on continuous improvement initiatives, filling technology upgrades, and CMO performance management.
Lead deviation investigations and drive CAPA closure for events occurring during or after filling operations; assess impact on batch and filing.
Track cycle times, yield trends, and reject rates across batches; analyze data for process drift and drive continuous improvement actions with the CMO.
Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
Key GMP decision-maker for external DP filling operations; apply FDA 21 CFR, EU GMP Annex 1, and USP/EP/JP compendia requirements.
Ensure CMO change controls are appropriately evaluated for regulatory impact; coordinate post-approval change strategies with Regulatory Affairs.
Review CMC sections of regulatory submissions (IND, BLA/NDA, MAA) related to DP manufacturing and filling as required.
Support GMP audits of CMO sites; identify compliance gaps, assess risk.
This role requires:
A Bachelor’s degree or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related discipline and 10+ years in pharmaceutical/biopharmaceutical DP manufacturing, with significant direct experience in sterile filling and CMO oversight. May substitute proven experience for education requirement.
Hands-on technical experience with sterile drug product filling operations (aseptic filling, lyophilization, CCI, inspection) in a GMP environment.
Demonstrated experience leading or executing tech transfer of DP filling processes to CMO sites,…