Principal External Manufacturing Specialist, Gene Therapy

Regeneron

. Serve as the operational contact for contract manufacturing and/or partner sites for day-to-day Gene Therapy Drug Substance and/or Drug Product Manufacturing activities .

Posted 11/12/2026full-timeEast Greenbush • New York • United StatesLead💰 $94,000 - $153,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in cGMP manufacturing operations and supplier management, with a strong focus on strategic partnerships, technical transfer activities, and regulatory filing support for drug substance and product manufacturing.

Highest-signal resume keywords

CGMP Manufacturing OperationsRegulatory Filing SupportTechnical Transfer ActivitiesSupplier ManagementContinuous Improvement Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Gene Therapy ManufacturingBatch SchedulingMaterial Supply ManagementCycle-Time TrackingValidation PlansMaster Manufacturing RecordsSOP DevelopmentMetrics DevelopmentProduct Launch CoordinationQuality Assurance Compliance

Soft Skills

CollaborationStrategic Partnership FormationProblem SolvingCommunicationLeadership

Industry Keywords

IND SubmissionsIMPD SubmissionsBLA SubmissionsMAA SubmissionsPlasmidViral VectorLNPCAR-TSupply Chain ManagementOperational Excellence

About the role

Key responsibilities & impact

Serve as the operational contact for contract manufacturing and/or partner sites for day-to-day Gene Therapy Drug Substance and/or Drug Product Manufacturing activities
Facilitate External Manufacturing activities, including batch scheduling, material supply, bulk product shipment, cycle-time tracking, monitoring, reporting, and technical expertise
Liaise between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, and contract manufacturers or business partners
Collaborate with New Product Launch Teams and Life Cycle Management Teams on product launches
Coordinate technical transfer activities, validation plans, master manufacturing records, SOPs, and other documentation
Support strategic initiatives and contract negotiations
Manage quarterly business reviews and governance structures with CMOs
Resolve supply issues affecting product quality or availability and coordinate internal and external resources
Ensure off-site inspections, testing, shipping, and packaging comply with guidelines and specifications
Monitor cGMP compliance at contract manufacturers
Support investigations concerning External Manufacturing or shipping operations
Provide regulatory filing support for IND, IMPD, BLA, and MAA submissions
Assist in developing metrics to analyze department activities, workload, and performance
Serve as the primary Regeneron technical contact for selected contract manufacturing sites

Requirements

What you’ll need

BS/BA in business or a scientific discipline and 8+ years of related experience in cGMP manufacturing operations or supplier management, or equivalent combination of education and experience
Experience in cGMP manufacturing operations (clinical and/or commercial) or supplier management
Experience in Plasmid, Viral Vector, LNP, or CAR-T Drug Substance and/or Drug Product is strongly preferred
Ability to form strategic partnerships with technical and operational colleagues and collaborate with departments and contractors
Ability to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies
Travel up to 25%

Benefits

Comp & perks

annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
medical, dental, vision, life and disability insurance benefits
paid time off
family support benefits
reasonable accommodation during the recruitment process where required