Supervisor, Manufacturing Batch Record Review
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About The Position
We're hiring a Supervisor, Batch Record Review, to provide oversite of documentation support for all pharmaceutical manufacturing activities in Baltimore, Maryland. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Supervisor, Batch Record Review is responsible for providing oversight and support to the functioning team for GMP documentation of master/working cell banks, bulk drug substance, and finished drug product. The supervisor is responsible for leading teams to execute the review and successful release of all batch records used in Catalent manufacturing, coordinating the company’s product release goals, team training, and team production goals. This is a full-time, salaried position and is 100% onsite. The schedule is a day shift 9am - 6pm Monday through Friday. Catalent’s FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus in Baltimore, Maryland. The campus, featuring two manufacturing facilities, supports Phase 3 through commercial manufacturing of advanced therapeutic products, including Adeno-associated Virus (AAV), and other viral vector-based therapies and vaccines. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
