Staff External Manufacturing Specialist (Clinical Drug Product)

Responsibilities

• 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.
• 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/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.
• 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.
• 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.
• 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.

Requirements

• A Bachelors 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.

Qualifications

• Proven experience 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.
• 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.
• 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.

Skills

• Deep technical knowledge of aseptic filling unit operations.
• Experience with sterile drug product filling operations (aseptic filling, lyophilization, CCI, inspection).
• Experience with tech transfer of DP filling processes to CMO sites.
• Experience with deviation investigations and CAPA development for sterile filling operations.
• Ability to mentor and develop technical staff.
• 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.

Benefits

• 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.
• Family support benefits.

Pay

• $108,000.00 - $176,000.00 annually

Schedule

• Monday-Friday