Supervisor, QA OTF

Position Summary 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. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. The Supervisor, QA OTF Support is responsible for providing quality oversight for the “QA on the Floor” program in accordance with Catalent policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations on the floor to resolve manufacturing issues. This position is required to be present on the floor for 70% of the day. This position is Night Shift 7PM-7AM 2-2-3 schedule and is 100% on site at BWI/Harmans, MD facility. 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. The Role Provide oversight of the “QA on the Floor” program. Supervision of OFT processes and personnel. Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. Build effective teams that apply their diverse skills and perspectives to achieve common goals. Monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor. Ensure manufacturing compliance with applicable procedures and batch records. Review manufacturing shop floor documentation, including logbooks, calibrations etc Other duties as assigned. The Candidate Masters’ degree with minimum 4 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. Scientific or life science discipline degree preferred OR Bachelor’s degree with minimum 6 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. Scientific or life science discipline degree preferred. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks. Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred. Requires the ability to produce results in a fast-paced environment to meet client deadlines.

Salary : $93,000 - $128,000