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Severn, Maryland, United States
Onsite
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.
We have an opportunity for a Supervisor, Manufacturing to join our team. In this role, you will lead teams to execute procedures for upstream manufacturing and support areas using standard operating procedures and batch records. You will oversee production equipment operations for upstream processing, including process monitoring, media preparation, and harvesting. You will ensure all team members are fully trained and compliant before entering the production floor, while maintaining high standards of quality and safety.
Shift: Day shift 7pm-7am on a 2-2-3 rotation
Location: Harmans, MD - BWI
100% Onsite
Supervise day-to-day manufacturing operations, personnel, and production activities to ensure safe, efficient, and compliant execution.
Lead, train, coach, and develop teams in GMP requirements, safety standards, and operational excellence.
Build high-performing, engaged teams by fostering collaboration, accountability, diversity, and continuous development.
Manage employee performance through coaching, performance reviews, hiring support, onboarding, and talent retention initiatives.
Ensure production batches meet quality, regulatory, and GMP requirements, including batch review and closeout with Quality Assurance.
Author, review, and maintain manufacturing documentation, including SOPs, batch records, logbooks, validation protocols, and related records.
Lead deviation investigations, CAPA activities, and compliance initiatives to drive quality improvements and regulatory readiness.
Partner with cross-functional groups, including QA, MS&T, Engineering,
Facilities, Project Management, and clients, to execute production campaigns and technology transfers.
Oversee critical manufacturing processes, equipment operation, maintenance coordination, validation activities, and accurate scientific data analysis.
Drive continuous improvement initiatives by identifying process efficiencies, resolving operational challenges, and providing regular production updates to stakeholders.
Other duties as assigned
Master’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of experience in upstream biologic production processes under Good Manufacturing Practice compliance OR
Bachelor’s degree in a Scientific, Engineering, or Biotech field with 6–8 years of experience in upstream biologic production processes under Good Manufacturing Practice compliance OR
High School Diploma or Associate Degree with 8–10 years of experience in upstream biologic production processes under Good Manufacturing Practice compliance
Experience in mammalian or microbial cell culture is required
Solid experience with large-scale centrifuges, washers, and autoclaves
Apply scientific and technical knowledge to solve routine production challenges, operate equipment effectively, and support manufacturing operations.
Maintain accurate GMP documentation, including batch records, SOPs, deviations, summary reports, and related manufacturing records.
Demonstrate strong communication, collaboration, and teamwork skills while working effectively with both technical and non-technical stakeholders.
Exhibit continuous learning, adaptability, creativity, and multitasking abilities, with a commitment to professional growth and process improvement.
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.
Experience with bacterial fermentation processes in a Good Manufacturing Practice environment, including bioreactor setup and operation, aseptic processing, process monitoring, sampling, troubleshooting, and batch record documentation
The anticipated salary range for this position in MD is $110,000 – $130,000 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.
Defined career path with annual performance reviews and feedback
Diverse and inclusive culture
Opportunities for career growth within an organization dedicated to improving lives
Competitive paid time off plus 8 paid holidays
Community engagement and green initiatives
Medical, dental, and vision benefits effective day one
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 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.
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