Supervisor, Fill Finish
About The Position
Our Gene Therapy facility, located at the University of Maryland (UMD) BioPark in the city of Baltimore, MD, specializes in upstream and downstream process development of viral vectors for clinical applications. The facility houses process development labs and CGMP cleanroom suites for Phase 1 and 2 programs focused on a variety of transformative technologies, including AAV and other viral vectors, vaccines, and oncolytic immunotherapies. 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.
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.
Nice To Haves
- Proven track record of leading or supervising hands-on cGMP manufacturing operations.
Responsibilities
- 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.
Benefits
- Competitive paid time off plus 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement program.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
