GMP Manufacturing Supervisor – Gene Therapy

Catalent; Harmans (MD); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Competitive benefits

Defined career path

Paid time off & holidays

Job summary

Catalent is seeking a Supervisor, Manufacturing in Harmans, MD to lead upstream bioprocess operations and ensure adherence to GMP, safety, and quality standards. The role requires training and developing teams, maintaining batch records, and driving continuous improvement.

You will oversee equipment operations, validation, and cross-functional collaboration across QA, MS&T, Engineering, and Facilities. This onsite position offers broad exposure to manufacturing campaigns and technology transfers

Qualifications

• Master’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of experience in upstream biologic production under GMP.
• Bachelor’s degree in a Scientific, Engineering, or Biotech field with 6–8 years of experience in upstream biologic production under GMP.
• High School Diploma or Associate Degree with 8–10 years of experience in upstream biologic production under GMP.
• 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.
• 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.

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 QA.
• 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

Skills

Leadership

GMP compliance

Safety standards

Operational excellence

Team coaching

Documentation

Education

Master’s degree in Science/Engineering/Biotech

Bachelor’s degree in Science/Engineering/Biotech

High school diploma or associate degree

Job description

Catalent is seeking a Supervisor, Manufacturing in Harmans, MD to lead upstream bioprocess operations and ensure adherence to GMP, safety, and quality standards. The role requires training and developing teams, maintaining batch records, and driving continuous improvement.

You will oversee equipment operations, validation, and cross-functional collaboration across QA, MS&T, Engineering, and Facilities. This onsite position offers broad exposure to manufacturing campaigns and technology transfers