Staff External Manufacturing Specialist (Clinical Drug Product)

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. 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 tech transfer of DP filling processes to CMO sites, including MBR/TRD approval, PPQ, and process validation. Experience leading deviation investigations and CAPA development for sterile filling operations. Demonstrated ability to mentor and develop technical staff; experience providing guidance in a team or lead capacity. Strong analytical, communication, and cross‑functional collaboration skills; ability to influence and make decisions in ambiguous situations. Willingness to travel domestically and internationally up to 25%+ as required. May substitute proven experience for the education requirement. Salary Range (annually) $108,000.00 - $176,000.00 Benefits include health and wellness programs (medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, see Regeneron's rewards page. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc