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 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). Coordinate and oversee DP manufacturing at CMO as dictated by project tech transfer and clinical operations. Liaise 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. Ensure product integrity and company reputation by monitoring 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 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 education requirement. Salary Range (annually) $108,000.00 – $176,000.00 We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. #J-18808-Ljbffr BioSpace