Lead Specialist, QA Batch Disposition

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 Lead Specialist, QA – Batch Disposition is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements. This is a full-time on-site position, Monday - Friday 8:30am – 5:30pm. 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 Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents. Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products. Independently executes batch record review for completeness, accuracy and cGMP compliance. Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent the Batch Disposition QA perspective as needed Other duties as assigned. The Candidate Masters’ degree with minimum 4 years’ experience biologic, biopharmaceutical, or regulated industry. Scientific or Life Science discipline degree preferred OR Bachelors’ degree with minimum 6 years’ experience biologic, biopharmaceutical, or regulated industry. Scientific or Life Science discipline degree preferred. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Strong working knowledge of biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Strong working knowledge with electronic systems, including developing and producing reports using Microsoft Office (Excel). Requires the ability to produce results in a fast-paced environment to meet client deadlines Strong technical and quality background related to pharmaceuticals. Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team. Able to work in a team setting and independently under minimum supervision. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Salary : $63,000 - $108,000