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About the Role

We are seeking a Staff External Manufacturing Specialist to serve as the technical and operational authority for clinical contract drug product (DP) filling operations at CMO and business partner sites. This role owns the tech transfer process end-to-end, drives active batch management, and is a key GMP decision-maker, providing technical mentorship and leadership.

Responsibilities

Apply deep technical knowledge of aseptic filling unit operations, including sterile filtration, filling, stoppering, capping, and lyophilization cycle development and scale-up.
Interpret environmental monitoring data, airborne particulate results, and media fill outcomes to assess batch disposition and process adequacy.
Partner with DP MSAT to evaluate and apply lessons learned across the network.
Assess cleanroom design and equipment suitability relative to product contamination control requirements.
Support extractables and leachables 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, including gap assessments, risk evaluations, facility/equipment readiness, and engineering run execution.
Approve Technical Requirements Documents (TRD), Master Batch Records (MBR), validation reports, and summary reports.
Oversee tech transfer, qualification, and validation of filling lines and critical equipment.
Coordinate and oversee DP manufacturing at CMO as dictated by project tech transfer and clinical operations.
Liaise between various Regeneron departments and contract manufacturers or business partners.
Serve as the primary technical resource for mid-level EM Specialists, providing hands-on guidance.
Coach Specialists on interpreting in-process data, applying GMP regulations, and escalating issues.
Lead sub-teams on continuous improvement initiatives, filling technology upgrades, and CMO performance management.
Collaborate with management to communicate CMO operational status, surface risks, and shape external manufacturing strategy.
Serve as Regeneron’s primary technical contact for all active clinical batches at CMO sites, tracking filling status, in-process results, and lot disposition milestones.
Monitor in-process data, including fill weight/volume checks, filter integrity test results, and visual/automated inspection outcomes.
Lead deviation investigations and drive CAPA closure for events occurring during or after filling operations.
Track cycle times, yield trends, and reject rates across batches, analyzing data for process drift and driving continuous improvement actions.
Ensure product integrity and company reputation through monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
Act as a key GMP decision-maker for external DP filling operations, applying regulatory requirements.
Ensure CMO change controls are appropriately evaluated for regulatory impact and coordinate post-approval change strategies.
Review CMC sections of regulatory submissions related to DP manufacturing and filling.
Support GMP audits of CMO sites, identifying compliance gaps and assessing risk.

Requirements

Bachelor’s degree or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related discipline.
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.

Skills

Aseptic filling unit operations
Sterile filtration
Lyophilization cycle development and scale-up
Environmental monitoring data interpretation
Media fill outcomes assessment
Extractables and leachables risk assessments
Tech transfer
Gap assessments
Risk evaluations
Facility/equipment readiness assessment
Engineering run execution
Technical Requirements Document (TRD) approval
Master Batch Records (MBR) approval
Validation reports approval
Process validation
Deviation investigations
CAPA development
GMP compliance
Regulatory affairs
CMC review
GMP audits
Analytical skills
Communication skills
Cross-functional collaboration
Decision-making

Location

Rensselaer, NY

Work Type

On-site

Experience Level

Staff level
10+ years

Education Level

Bachelor's degree or advanced degree

Salary/Compensations

$108,000.00 - $176,000.00

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

About the Company

We are committed to building a workplace with an inclusive culture.
Regeneron offers a competitive and comprehensive total rewards package.
We believe we do our best work when we are together.
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.

Equal Opportunity

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.