Manager, Manufacturing, Fill Finish; Drug Product

Manager, Manufacturing, Fill Finish Position Summary

Work Schedule:

Monday – Friday, 8am-5pm. 100% on-site.

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. This hands‑on, floor‑focused leadership role requires 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).

• 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.

• 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 leadership programs) 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 behavior, environmental monitoring, and contamination control. Experience with lyophilization, visual inspection, and packaging interfaces is preferred.
• Able to work effectively in a team setting and independently with minimal supervision; strong cross‑functional communication skills.
• Demonstrated ability to deliver results in a fast‑paced GMP…