Supervisor, Manufacturing

Catalent Pharma Solutions•Glen Burnie, MD

8d•$110,000 - $130,000•Onsite

About The Position

Catalent is hiring a Supervisor, Manufacturing for its Harmans/BWI campus in Harmans, Maryland. The campus supports Phase 3 through commercial manufacturing of gene therapies and other advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. The FDA- and EMA-approved BWI-1 facility includes CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse; BWI-2 is under development. The Supervisor will lead teams executing upstream manufacturing procedures and support-area activities using SOPs and batch records. The role oversees upstream production equipment and processes, including process monitoring, media preparation, and harvesting, and ensures employees are trained and compliant before entering production areas. The Supervisor is responsible for safe, efficient, high-quality, and compliant manufacturing operations, personnel development, documentation, investigations, and continuous improvement. This is a 100% onsite position with a 7 p.m.–7 a.m. day-shift schedule on a 2-2-3 rotation.

Requirements

One of the following education and experience combinations in upstream biologic production processes under GMP compliance: a master's degree in a scientific, engineering, or biotech field and 4–6 years of experience; a bachelor's degree in one of these fields and 6–8 years of experience; or a high school diploma or associate degree and 8–10 years of experience.
Experience in mammalian or microbial cell culture.
Solid experience with large-scale centrifuges, washers, and autoclaves.
Ability to apply scientific and technical knowledge to solve routine production challenges, operate equipment effectively, and support manufacturing operations.
Ability to maintain accurate GMP documentation, including batch records, SOPs, deviations, summary reports, and related manufacturing records.
Strong communication, collaboration, and teamwork skills, including the ability to work effectively with technical and non-technical stakeholders.
Continuous learning, adaptability, creativity, multitasking ability, and commitment to professional growth and process improvement.

Nice To Haves

Experience with bacterial fermentation processes in a GMP environment, including bioreactor setup and operation, aseptic processing, process monitoring, sampling, troubleshooting, and batch record documentation.
Demonstrable leadership experience at Catalent, including participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW, may be considered in place of external experience.

Responsibilities

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.
Foster collaboration, accountability, diversity, and continuous development to build engaged, high-performing teams.
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 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 by identifying process efficiencies, resolving operational challenges, and providing regular production updates to stakeholders.
Perform other duties as assigned.