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Manager, Central Services
Catalent
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About this role
Manager, Central Services
About Site 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.
Position Summary We have an opportunity for a Manager, Central Services to join our team. This role leads a team of professionals and oversees GMP manufacturing processes for buffer and media preparation. You will plan and manage production operations, including start-up and product changeover activities, while supporting both daily tasks and long-term projects. This position plays a key role in ensuring process optimization, efficiency, and compliance with industry standards.
Shift: Monday - Friday, 8am - 5pm Location: Harmans, MD - BWI 100% Onsite
The Role • Manage buffer and media weigh/dispense/production suites, clean/sterile assembly preparation, raw material sampling and dispensing. • Drive the design, acquisition, and implementation of new technologies for buffer and media preparation. • Assist with the transfer of new buffers and media formulations working with GMP Operations and Development laboratory personnel. • Provide overall supervision for cGMP suite cleaning, waste removal, stocking of consumables, and movement of raw materials and solutions within the suites. • Provide direct supervision, training, and hands-on support of production staff in equipment operation for preclinical, clinical, and commercial batches. • Coordinate and supervise department change-over activities and serve as equipment and suite owner for maintenance, calibration, and validation. • Coordinate preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including deviations for each campaign. • Assist in troubleshooting equipment issues and batch/material deviations, and provide timely reporting and resolution of process/product deviations and change controls. • Ensure adherence to cGMP guidelines, industry safety standards, and OSHA guidelines. • Interact cross-functionally with internal and external teams to support successful batch production. • Recruit, train, and develop staff, ensuring training in cGMPs, process knowledge, equipment operation, and regulations. • Partner with Sr. Director to strategize plans for resource optimization and operational goals. • Build effective teams and drive engagement to create a culture of excellence. • Ensure quality culture through continuous pursuit of right first-time performance. • Other duties as assigned.
The Candidate Minimum Requirements • Bachelor’s Degree with 8+ years of directly related experience OR Associate’s Degree with 10+ years of directly related experience. • 6+ years prior manufacturing experience in the pharmaceutical or biotechnology industry with demonstrated high performance. • Proficient understanding of FDA cGMP regulations. • 4 years of direct or progressive people leadership experience. • Strong scientific and technical expertise with the ability to apply principles to solve production and operational challenges while demonstrating a solid understanding of equipment function and application. • Committed to safety, consistently promoting safe behaviors and identifying potential hazards or unsafe conditions. • Thorough knowledge of quality systems in regulated environments, with a focus on compliance, right-first-time execution, and continuous improvement. • Excellent documentation and computer skills, including experience with SOPs, SMPs, deviations, summary reports, and proficiency in Microsoft Office applications. • Collaborative team player who builds strong cross-functional relationships while actively pursuing new skills, training, and equipment knowledge. • Ability to work a set shift with occasional overtime as required. • 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.
Pay The anticipated salary range for this position in MD is $135,000 – $165,000 Plus Bonus. 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 • Defined career path and annual performance review and feedback process. • Diverse, inclusive culture. • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. • Competitive paid time off plus 8 paid holidays. • Community engagement and green initiatives. • Medical, dental, and vision benefits effective day one of employment. • Tuition Reimbursement.
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 wo
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