Supervisor, Manufacturing Batch Record Review

Supervisor, Manufacturing Batch Record Review

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, Manufacturing 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 on-site salaried position. Monday - Friday, 8:30am - 5:30pm

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. 

The Role

• Supervision of manufacturing review processes and personnel

• Ensure the completeness and accuracy of manufacturing documentation by approved procedures

• cGMP batch review and close-out with Quality Assurance group

• Ensure staff are fully trained in appropriate cGMP manufacturing review operations and documentation and adhering to safety guidelines

• Ensure batches adhere to established Quality standards

• Build effective teams that apply their diverse skills and perspectives to achieve common goals

• Drive engagement and create a culture where employees are motivated to do their best

• Other duties, as assigned

The Candidate

• Requires Masters’ degree in a Scientific, Engineering or Biotech field with a minimum of 4 years’ direct or indirect experience with biologic production processes, under cGMP compliance OR

• Bachelor’s degree in Scientific, Engineering or Biotechnology fields, with a minimum of 6 years’ direct or indirect experience with biologic production processes, under cGMP compliance OR

• High School Diploma or associate’s degree with a minimum of 8 years’ direct or indirect experience with biologic production processes, under cGMP compliance

• Minimum of 2 years’ experience related to cGMP record review, highly preferred

• Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports

• Prior professional leadership experience required

The anticipated salary range for this position in Maryland is $93,280 - $128,260 plus shift differential and annual bonus, when eligible.  The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent

• Medical, dental, vision, and wellness benefits are effective on the first day of employment.

• Potential for career growth on an expanding team and organization.

• 152 hours of paid time off annually plus 8 paid holidays.