Supervisor, Fill Finish
Catalent Pharma Solutions
Summary
We have an opportunity for a Supervisor, Fill Finish to join our team supporting GMP Fill Finish manufacturing processes. This role applies broad knowledge of theories, techniques, and principles to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II and commercial GMP manufacturing. The Supervisor plays a key role in ensuring patient safety by manufacturing life-saving medicines right the first time. Quality, safety, and on-time delivery are essential to success in this position. The Supervisor Fill/Finish reports to the Manager, Manufacturing - Fill/Finish.
Job description
Position Summary
We have an opportunity for a Supervisor, Fill Finish to join our team supporting GMP Fill Finish manufacturing processes. This role applies broad knowledge of theories, techniques, and principles to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II and commercial GMP manufacturing. The Supervisor plays a key role in ensuring patient safety by manufacturing life-saving medicines right the first time. Quality, safety, and on-time delivery are essential to success in this position. The Supervisor Fill/Finish reports to the Manager, Manufacturing - Fill/Finish.
Shift: 2nd shift, Monday - Friday, 2pm-10:30pm. Location: Baltimore, MD - BioPark 100% Onsite
The Role
- Produce clinical and commercial material annually that meets site objectives and complies with cGMPs and safety regulations.
- Serve as the point person on shift to assign and distribute work and coordinate emergency situations.
- Ensure documentation, including batch records and standard operating procedures, is accurate and updated as required.
- Oversee safe, environmentally responsible, and quality-compliant manufacturing operations.
- Facilitate GMP and safety training for staff, focusing on cross-training and continuous improvement.
- Recommend equipment and supply purchases within production areas.
- Exhibit safety leadership by example, using proper personal protective equipment when performing job functions.
- Demonstrate understanding of operations performed in the production unit.
- Manage shift schedules and summarize progress at the end of each shift.
- Lead and mentor staff, conduct performance reviews, set annual goals, and hold one-on-one meetings.
- Communicate departmental results effectively through team discussions and documentation.
- Ensure cGMP compliance in all documentation, reports, and records.
- Initiate non-conformances and complete investigations to support timely closure of deviations.
- Review current regulations, industry guidance, and other applicable professional documentation.
- Perform other duties as assigned.
The Candidate
Minimum Requirements
- Master’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of biopharmaceutical GMP manufacturing experience, including fill/finish processes and understanding of the drug development lifecycle; OR
- Bachelor’s degree in a Scientific, Engineering, or Biotech field with 6–8 years of biopharmaceutical GMP manufacturing experience, including fill/finish processes and understanding of the drug development lifecycle; OR
- High school diploma or associate degree with 8–10 years of biopharmaceutical GMP manufacturing experience, including fill/finish processes and understanding of the drug development lifecycle.
- Strong experience in GMP fill/finish manufacturing operations with a solid understanding of the drug development process.
- Extensive knowledge of fill/finish manufacturing, including aseptic hand filling and automated liquid vial filling.
- Proven ability to coordinate cross-functional manufacturing activities to meet production schedules and objectives.
- Demonstrated leadership skills, with the ability to deliver results in a fast-paced environment while motivating, mentoring, and developing teams.
- Strong troubleshooting and problem-solving capabilities grounded in scientific and engineering principles, with a focus on continuous improvement.
- Excellent verbal and written communication skills; position requires full onsite presence with no remote or hybrid work option.
- 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 & Background
- Proven track record of leading or supervising hands-on cGMP manufacturing operations.
Requirements
- Master’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of biopharmaceutical GMP manufacturing experience, including fill/finish processes and understanding of the drug development lifecycle
- Bachelor’s degree in a Scientific, Engineering, or Biotech field with 6–8 years of biopharmaceutical GMP manufacturing experience, including fill/finish processes and understanding of the drug development lifecycle
- High school diploma or associate degree with 8–10 years of biopharmaceutical GMP manufacturing experience, including fill/finish processes and understanding of the drug development lifecycle
- Strong experience in GMP fill/finish manufacturing operations with a solid understanding of the drug development process
- Extensive knowledge of fill/finish manufacturing, including aseptic hand filling and automated liquid vial filling
- Proven ability to coordinate cross-functional manufacturing activities to meet production schedules and objectives
- Demonstrated leadership skills, with the ability to deliver results in a fast-paced environment while motivating, mentoring, and developing teams
- Strong troubleshooting and problem-solving capabilities grounded in scientific and engineering principles, with a focus on continuous improvement
- Excellent verbal and written communication skills
- Position requires full onsite presence with no remote or hybrid work option
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 8 Paid Holidays
- Tuition Reimbursement
- Career Development Programs
- Community Engagement
- Green Initiatives
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.