Senior Drug Product MSAT Engineer
Regeneron
August 12, 2026
On-site
Rensselaer, NY
Operations
Discover Your Role
- Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products.
- Acts as technical lead (with multi-functional teams) for technology transfer of drug product manufacturing processes to manufacturing facilities.
- Tracks and reports project milestones (raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.).
- Reviews and approves cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.).
- Assists with investigations: root cause determination and CAPA identification/implementation for manufacturing deviations.
- Trends process performance and collaborates to establish/improve process performance and process capability within the intended process control strategy.
- Authors technical reports/protocols supporting cGMP activities.
- Supports development of sampling plans for cGMP batches (process characterization, process qualification, lot release, stability, etc.).
- Assists in equipment selection, qualification, and start-up; partners with manufacturing to ensure robust equipment procedures.
- Partners with strategic sourcing/procurement to specify technical requirements for raw materials, components, equipment and services.
- Supports 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.
Application
- Apply now.
- Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products.
- Acts as technical lead (with multi-functional teams) for technology transfer of drug product manufacturing processes to manufacturing facilities.
- Tracks and reports project milestones (raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.).
- Reviews and approves cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.).
- Assists with investigations: root cause determination and CAPA identification/implementation for manufacturing deviations.
- Trends process performance and collaborates to establish/improve process performance and process capability within the intended process control strategy.
- Authors technical reports/protocols supporting cGMP activities.
- Supports development of sampling plans for cGMP batches (process characterization, process qualification, lot release, stability, etc.).
- Assists in equipment selection, qualification, and start-up; partners with manufacturing to ensure robust equipment procedures.
- Partners with strategic sourcing/procurement to specify technical requirements for raw materials, components, equipment and services.
- Supports 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.
Application
- Apply now.