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 rotating 7:00AM – 7:00PM schedule (2 days on, 2 days off, 3 days on rotation.)
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
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.
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.
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.
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.
Community engagement and green initiatives.
Engaging D&I Employee Resource Groups.
Tuition reimbursement program.
Generous 401K match.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
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