Manager, Manufacturing, Fill Finish; Drug Product

Position: Manager, Manufacturing, Fill Finish (Drug Product)
Manager, Manufacturing, Fill Finish

Position Summary:

• Work Schedule:
  Monday - Friday, 8am-5pm
• 100% on-site

Catalent is a leading global CDMO, partnering with pharmaceutical, biotech, and self-care companies to accelerate the development, manufacturing, and delivery of life-changing therapies, and our Gene Therapy facility at the University of Maryland (UMD) Bio Park in Baltimore, MD specializes in upstream and downstream viral vector process development for clinical programs, with advanced development labs and cGMP cleanroom suites supporting Phase 1 and 2 programs across AAV, vaccines, and oncolytic immunotherapies within a highly collaborative biotech and research hub.

The Manager, Manufacturing Fill/Finish Drug Product is responsible for the safe, compliant, and efficient execution of sterile drug product manufacturing operations, leading teams and cross-functional partners to deliver campaign and batch objectives across formulation, sterile filtration, aseptic filling, stoppering/capping, inspection, and batch disposition readiness.

As fill-finish operations from technology transfer through routine GMP manufacturing, this leader establishes a culture of right-first-time execution, aseptic discipline, contamination control, and continuous improvement. The role partners closely with MS&T, Quality, Supply Chain, Engineering/Facilities, Validation, and Project Management to ensure manufacturing readiness, schedule adherence, deviation reduction, and robust investigation and CAPA execution.

This is a hands-on, floor-focused leadership role requiring deep technical understanding of sterile drug product manufacturing, strong people leadership, and the ability to drive performance through data, standard work, and operational rigor. The position interfaces routinely with clients and auditors and is accountable for meeting safety, quality, delivery, and cost targets for the fill-finish drug product area.

This role reports directly to the Director - Manufacturing Fill/Finish (Drug Product Operations).

The Role:

• Foster a strong quality culture prioritizing data integrity, aseptic discipline, right-first-time execution, and continuous improvement.
• Lead day-to-day sterile drug product manufacturing operations, ensuring strict adherence to batch records, SOPs, gowning, and aseptic processing standards.
• Drive production performance against schedule, yield, efficiency, and cycle-time targets while monitoring KPIs and closing performance gaps.
• Ensure shift readiness across materials, equipment, personnel, documentation, and environmental monitoring to support uninterrupted manufacturing.
• Provide visible floor leadership, reinforcing safety, contamination control, minimal interventions, and strong documentation practices.
• Build, coach, and develop a high-performing fill-finish team through clear expectations, onboarding, and ongoing performance feedback.
• Partner cross-functionally with Engineering and Facilities to maintain reliability and availability of critical sterile manufacturing equipment.
• Support commissioning, qualification, and validation (IQ/OQ/PQ, media fills, smoke studies, sterilization, cleaning, CCI) to ensure operational readiness.
• Ensure compliant setup, cleaning, changeovers, and line clearance for multi-product operations with strong contamination control and segregation practices.
• Maintain GMP compliance (FDA 21 CFR 210/211, aseptic guidance, EU Annex
  1), support audits/inspections, implement KPI tracking, and lead root-cause initiatives to reduce deviations and sterility risks.
• Other duties as assigned

The Candidate:

• Master's degree in a scientific, engineering, pharmaceutical, or biotechnology field with a minimum of 5 years' experience in GMP sterile drug product or fill finish manufacturing operations within biopharmaceuticals, biologics, vaccines, or related industries OR
• Bachelor's degree in a scientific, engineering, pharmaceutical, or biotechnology field with a minimum of 8 years' experience in GMP sterile drug product or fill finish manufacturing operations within biopharmaceuticals, biologics, vaccines, or related industries.
• 2+ years of people management experience. Experience leading supervisors and/or aseptic manufacturing teams preferred.
• 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.
• Familiarity with electronic manufacturing and quality systems (e.g., EMS, deviation/CAPA systems, CMMS) and ability to generate and interpret production, sterility assurance, and quality metrics.
• Strong analytical and troubleshooting skills with the ability to make sound decisions under pressure; demonstrated root-cause analysis and continuous improvement experience.
• Strong understanding of sterile drug product manufacturing processes and controls, including formulation, sterile filtration, aseptic filling, container closure systems, cleanroom…