Supervisor, Fill Finish

Job description

Supervisor, Fill Finish Role About SiteOur 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. Baltimore is a hub of national and international travel and communications and is also home to and near major universities and several federal agencies, including the FDA, USDA, NIH, Johns Hopkins University, and UMD Schools of Medicine. 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. Position SummaryWe 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 RoleProduce 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 CandidateMinimum RequirementsMaster’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 & BackgroundProven track record of leading or supervising hands-on cGMP manufacturing operations. PayThe 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 depend on factors such as experience, skillset, education, and business needs. Catalent is a multi-state employer, and this range may not reflect positions in other states. Why You Should Join CatalentDefined career path with annual performance reviews and feedback. Diverse and inclusive culture. Opportunities for career growth within an organization dedicated to improving and saving lives. Competitive paid time off plus 8 paid holidays. Community engagement and green initiatives. Medical, dental, and vision benefits effective on the first day of employment. Tuition reimbursement program. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. 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