Principal Manufacturing Sciences & Technology Engineer
Regeneron
August 18, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Serves as technical lead and subject matter expert for drug product manufacturing process transfer; provides oversight for new product introduction, technology transfer, and process troubleshooting/issue resolution.
- Tracks and reports project milestones (raw material/component procurement, equipment readiness, analytical transfer, documentation) and partners with/leads cross-functional internal and external teams to ensure successful transfer execution.
- Reviews and approves cGMP batch documentation (master batch records, specifications, validation protocols) and authors policies, technical reports, protocols, and change controls.
- Monitors cGMP compliance at drug product contract manufacturers to protect product integrity.
- Trends process performance to establish and improve process capability and maintain operations within the intended control strategy.
- Investigates deviations; determines root cause; identifies/implements CAPA; develops sampling plans for GMP batches (lot release, stability, characterization).
- Collaborates with internal/external teams to improve process performance and cGMP operations.
- Leads or assists in equipment selection, qualification, and start-up activities; works with Manufacturing to ensure robust operating procedures.
- Partners with Strategic Sourcing/Procurement to define technical requirements for raw materials, components, equipment, and services.
This Role Requires
- BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred.
- Principal MSAT Engineer: 8+ years relevant experience; Staff MSAT Engineer: 10+ years relevant experience.
- Demonstrated technical knowledge in drug product manufacturing, product development, and validation; experience with Contract Manufacturing Organizations.
- Strong knowledge of industry practices and regulations (cGMP, Annex I) across FDA, EMA, and MHRA.
Location/Work model/Travel
- East Greenbush, New York, United States; Mon–Fri 8am–4:30pm; 25–50% domestic travel, occasional international.
- Serves as technical lead and subject matter expert for drug product manufacturing process transfer; provides oversight for new product introduction, technology transfer, and process troubleshooting/issue resolution.
- Tracks and reports project milestones (raw material/component procurement, equipment readiness, analytical transfer, documentation) and partners with/leads cross-functional internal and external teams to ensure successful transfer execution.
- Reviews and approves cGMP batch documentation (master batch records, specifications, validation protocols) and authors policies, technical reports, protocols, and change controls.
- Monitors cGMP compliance at drug product contract manufacturers to protect product integrity.
- Trends process performance to establish and improve process capability and maintain operations within the intended control strategy.
- Investigates deviations; determines root cause; identifies/implements CAPA; develops sampling plans for GMP batches (lot release, stability, characterization).
- Collaborates with internal/external teams to improve process performance and cGMP operations.
- Leads or assists in equipment selection, qualification, and start-up activities; works with Manufacturing to ensure robust operating procedures.
- Partners with Strategic Sourcing/Procurement to define technical requirements for raw materials, components, equipment, and services.
This Role Requires
- BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred.
- Principal MSAT Engineer: 8+ years relevant experience; Staff MSAT Engineer: 10+ years relevant experience.
- Demonstrated technical knowledge in drug product manufacturing, product development, and validation; experience with Contract Manufacturing Organizations.
- Strong knowledge of industry practices and regulations (cGMP, Annex I) across FDA, EMA, and MHRA.
Location/Work model/Travel
- East Greenbush, New York, United States; Mon–Fri 8am–4:30pm; 25–50% domestic travel, occasional international.