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, as needed, for internal or external manufacturing, 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, acting as the technical lead, for technology transfer of the drug product manufacturing processes to manufacturing facilities Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc. Reviewing and approving cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities Assisting with investigation and root cause determination and CAPA identification and implementation for manufacturing deviations Trending process performance and collaborates with internal and external teams to establish/improve process performance, process capability to ensure process is operating within intended process control strategy Authoring technical reports/protocols in support of cGMP activities Supporting development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc. Assisting in equipment selection, qualification, and start‑up activities and working with manufacturing to ensure robust procedures are used for operation of equipment Partnering with strategic sourcing/procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on‑time delivery Supporting the drafting of regulatory filings and responding to regulatory information requests This role requires BS in Engineering; chemical engineering or biomedical engineering preferred and 5+ years of relevant experience Regeneron is an equal‑opportunity employer and 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. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Salary Range (annually) $78,700.00 - $128,700.00 #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc