External Manufacturing Specialist, Advanced Therapies
Regeneron
August 25, 2026
On-site
East Greenbush, NY
Operations
Responsibilities:
- Serve as the operational contact for contract manufacturing and/or partner sites regarding day-to-day activities.
- Coordinate external manufacturing activities at contract/business partner sites: schedule batches, ensure material supply, direct shipment of materials, track/monitor cycle times, and obtain needed reports/technical expertise.
- Liaison between Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, and contract manufacturers/partners.
- Support investigations and associated shipping operations.
- Support and advise critical initiatives and contracts to strengthen long-term partner stability and success.
- Assist in monitoring cGMP compliance at contract manufacturers/partners to ensure product integrity.
- Support tech transfer and/or CMO development work to enable scalability toward GMP manufacturing.
- Review pre-production master batch records and executed batch records.
Qualifications/Requirements:
- BS/BA in a scientific field and related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education/experience.
- Associate Specialist: 0–2 years
- Specialist: 2+ years (level based on experience)
- Experience with synthetic-based processes, small molecule synthesis, antibody drug conjugates, and/or fermentation.
- Knowledge of bulk manufacturing techniques (fermentation, chemical synthesis, downstream purification, conjugation and/or formulation) (recommended).
- Basic regulatory compliance knowledge: cGMP, FDA regulations, ICH guidelines, and EU regulations.
- Strong interpersonal, written, and oral communication skills.
- Ability to work toward goals with minimal supervision; resiliency and flexibility in a dynamic environment.
Application:
- Apply now.
- Serve as the operational contact for contract manufacturing and/or partner sites regarding day-to-day activities.
- Coordinate external manufacturing activities at contract/business partner sites: schedule batches, ensure material supply, direct shipment of materials, track/monitor cycle times, and obtain needed reports/technical expertise.
- Liaison between Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, and contract manufacturers/partners.
- Support investigations and associated shipping operations.
- Support and advise critical initiatives and contracts to strengthen long-term partner stability and success.
- Assist in monitoring cGMP compliance at contract manufacturers/partners to ensure product integrity.
- Support tech transfer and/or CMO development work to enable scalability toward GMP manufacturing.
- Review pre-production master batch records and executed batch records.
Qualifications/Requirements:
- BS/BA in a scientific field and related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education/experience.
- Associate Specialist: 0–2 years
- Specialist: 2+ years (level based on experience)
- Experience with synthetic-based processes, small molecule synthesis, antibody drug conjugates, and/or fermentation.
- Knowledge of bulk manufacturing techniques (fermentation, chemical synthesis, downstream purification, conjugation and/or formulation) (recommended).
- Basic regulatory compliance knowledge: cGMP, FDA regulations, ICH guidelines, and EU regulations.
- Strong interpersonal, written, and oral communication skills.
- Ability to work toward goals with minimal supervision; resiliency and flexibility in a dynamic environment.
Application:
- Apply now.