Senior Drug Product MSAT Engineer

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is seeking a Senior Drug Product (DP) Manufacturing Sciences and Technology (MSAT) Specialist to join our Process Science Drug Product Engineering department. The Drug Product Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, management of equipment qualification, and process validation activities, and will be responsible for solving issues during technology transfer and cGMP start‑up for internal or external manufacturing sites. They also provide on‑floor support during operations, review process data to ensure operational consistency, and provide support for investigations. When & Where Location: Rensselaer, New York, United States Monday‑Friday, 8am‑4:30pm 25-50% travel domestic & occasionally internal 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 With the support of multi‑functional teams, act as the technical lead for technology transfer of the drug product manufacturing processes to manufacturing facilities Track and report project milestones related to 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.) required to support cGMP production at manufacturing facilities Assist with investigation and root cause determination and CAPA identification and implementation for manufacturing deviations Trend process performance and collaborate with internal and external teams to establish/improve process performance and process capability to ensure the process is operating within intended process control strategy Author technical reports/protocols in support of cGMP activities Support development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability, etc. Assist in equipment selection, qualification, and start‑up activities and work with manufacturing to ensure robust procedures are used for operation of equipment Partner with strategic sourcing/procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on‑time delivery Support drafting of regulatory filings and respond to regulatory information requests This Role Requires BS in Engineering; chemical engineering or biomedical engineering preferred 5+ years of relevant experience Salary Range (annually) $78,700.00 - $128,700.00 Equal Employment Opportunity Regeneron is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. We provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship. #J-18808-Ljbffr Regeneron