Senior Drug Product MSAT Engineer
Regeneron
June 29, 2026
On-site
Rensselaer, NY
Operations
Discover Your Role:
- Provide drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting, and issue resolution for biopharmaceutical drug products.
- Act as technical lead for technology transfer of drug product manufacturing processes to manufacturing facilities.
- Track and report project milestones (raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.).
- Review and approve cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) to support cGMP production.
- Assist with investigations, root cause determination, and CAPA identification/implementation for manufacturing deviations.
- Trend process performance and collaborate to establish/improve process performance and capability within the intended process control strategy.
- Author technical reports/protocols in support of cGMP activities.
- Support development of sampling plans for cGMP batches (process characterization, process qualification, lot release, stability, etc.).
- Assist with equipment selection, qualification, and start-up; work with manufacturing to ensure robust operating procedures.
- Partner with strategic sourcing/procurement on technical requirements for raw materials, components, equipment, and services.
- Support drafting regulatory filings and responding to regulatory information requests.
This Role Requires:
- BS in Engineering; chemical engineering or biomedical engineering preferred.
- 5+ years of relevant experience.
Location/Schedule (when & where):
- Rensselaer, New York, United States; Monday–Friday, 8:00am–4:30pm; 25–50% domestic travel (occasionally internal).
- Provide drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting, and issue resolution for biopharmaceutical drug products.
- Act as technical lead for technology transfer of drug product manufacturing processes to manufacturing facilities.
- Track and report project milestones (raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.).
- Review and approve cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) to support cGMP production.
- Assist with investigations, root cause determination, and CAPA identification/implementation for manufacturing deviations.
- Trend process performance and collaborate to establish/improve process performance and capability within the intended process control strategy.
- Author technical reports/protocols in support of cGMP activities.
- Support development of sampling plans for cGMP batches (process characterization, process qualification, lot release, stability, etc.).
- Assist with equipment selection, qualification, and start-up; work with manufacturing to ensure robust operating procedures.
- Partner with strategic sourcing/procurement on technical requirements for raw materials, components, equipment, and services.
- Support drafting regulatory filings and responding to regulatory information requests.
This Role Requires:
- BS in Engineering; chemical engineering or biomedical engineering preferred.
- 5+ years of relevant experience.
Location/Schedule (when & where):
- Rensselaer, New York, United States; Monday–Friday, 8:00am–4:30pm; 25–50% domestic travel (occasionally internal).