Senior Drug Product MSAT Engineer

Overview Regeneron is seeking a Senior Drug Product (DP) Manufacturing Sciences and Technology (MSAT) Specialist to join the Process Science Drug Product Engineering department. The role supports equipment selection, equipment qualification, process validation, technology transfer, cGMP start‑up, and on‑floor support for internal or external manufacturing sites. Responsibilities Provide drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, troubleshooting, and issue resolution for biopharmaceutical drug products. Act as the technical lead for technology transfer of drug product manufacturing processes to manufacturing facilities. Track and report project milestones related to raw material/component procurement, equipment readiness, process transfer, and manufacturing document creation. Review and approve cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications). Assist with investigations, root‑cause determination, and CAPA identification and implementation for manufacturing deviations. Trend process performance and collaborate with internal and external teams to establish and improve process performance and capability within the intended process control strategy. Author technical reports and protocols in support of cGMP activities. Support development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, and stability. Assist in equipment selection, qualification, and start‑up activities and ensure robust procedures are used for equipment operation. Partner with strategic sourcing/procurement to specify technical requirements for raw materials, components, equipment, and services and ensure on‑time delivery of external vendors. Support drafting of regulatory filings and respond to regulatory information requests. Qualifications BS in Engineering (chemical engineering or biomedical engineering preferred) with 5+ years of relevant experience. Location & Schedule Rensselaer, New York, United States. Monday-Friday, 8:00 am - 4:30 pm. 25-50% domestic travel and occasional internal travel. Compensation & Benefits Salary Range (annually): $78,700 - $128,700. Annual bonuses or other incentive plans. Equity awards. Pension or retirement benefits. 401(k) company match. Health and wellness programs. Fitness centers. Insurance benefits (medical, dental, vision, life and disability). Paid time off. Family support benefits. Equal Opportunity Employer Regeneron is an equal-opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, gender expression, age, disability, nationality, religious or cultural tradition, immigrant status, or any other characteristic protected by law. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)