Supervisor, Manufacturing

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus features two manufacturing facilities, is 5 miles from Baltimore Washington International (BWI) airport, and 13 miles from our Baltimore location. It is close to Washington, DC’s I-295 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 facility is EMA and FDA approved, spans approximately 200,000 sq. ft., and 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.

About the role

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: Night shift 7pm-7am on a 2-2-3 rotation
Location: Harmans, MD - BWI (100% Onsite)

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.
• 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.

Requirements

• 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.

Preferred Skills

• 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.

Pay

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 including but not limited to: type and length of experience within the job, type and length of experience within the industry, skillset, education, and business needs.

Benefits

• 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.