Staff External Manufacturing Specialist (Clinical Drug Product)

About the role

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: Rensselaer, NY Monday-Friday Discover your role: Drug Product Filling - Technical Expertise 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. Technical Transfer: 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 Oversee tech transfer, qualification, and validation of filling lines and critical equipment: isolator/RABS, vial/syringe filling systems, lyophilizers, and component prep (depyrogenation tunnels, washers, autoclave). Coordinates/oversees DP manufacturing at CMO as dictated by project tech transfer and clinical operations. 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. Technical Mentorship & Leadership 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. Coach Specialists on interpreting in-process data, applying GMP regulations to real-world filling scenarios, and escalating issues appropriately. Lead sub-teams on continuous improvement initiatives, filling technology upgrades, and CMO performance management. Collaborate with management to communicate CMO operational status, proactively, surface risks, and shape external manufacturing strategy. Active Batch Management: Serve as Regeneron's primary technical contact for all active clinical batches at CMO sites - track filling status, in-process results, and lot disposition milestones in real time. Monitor in-process data: fill weight/volume checks, filter integrity test results, visual/automated inspection outcomes, and lyophilization cycle data. 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. Lead sub-teams in continuous process improvements, system/equipment implementation and/or strategy development. Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners. Regulatory & GMP Compliance 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. Hands-on technical experience with sterile drug product filling operations (aseptic filling, lyophilization, CCI, inspection) in a GMP environment. Demonstrated experience leading or executing

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