Sr. Manager, Manufacturing Operations - Plasmids

About the role

Foster a strong Quality Culture emphasizing data integrity, right‑first‑time execution, safety, and continuous improvement across plasmid DNA manufacturing operations. Own day‑to‑day execution of plasmid DNA manufacturing activities, ensuring adherence to approved batch records, SOPs, aseptic/non‑aseptic controls, and documentation requirements. Drive production performance to meet schedule, yield, and cycle‑time targets by monitoring KPIs, identifying gaps, and implementing corrective actions. Ensure manufacturing readiness each shift, including materials availability, equipment status, room readiness, line clearance, personnel training compliance, and documentation preparedness. Provide visible, hands‑on leadership on the manufacturing floor, reinforcing safe work practices, contamination control behaviors, and strong GMP documentation standards. Lead, coach, and develop a high‑performing manufacturing team through onboarding, performance feedback, engagement, accountability, and effective shift coverage and escalation models. Ensure personnel qualification and training compliance in partnership with Quality and Training, supporting on‑the‑job training, proficiency sign‑offs, and curriculum completion. Own and support manufacturing investigations (deviations, nonconformances) and CAPAs, ensuring timely root‑cause analysis, effective corrective actions, and cross‑functional alignment. Partner with Engineering and Facilities to maintain equipment reliability and availability, supporting PMs, calibrations, troubleshooting, validation activities, and operational readiness for new equipment or processes. Collaborate cross‑functionally with MS&T, Quality, Supply Chain, Warehouse, and Project Management to execute production plans, support technology transfer, and resolve constraints impacting delivery. Ensure compliance with global GMP and regulatory requirements (FDA 21 CFR 210/211, ICH Q‑series, EU Annex 2, USP ), and support regulatory inspections and client audits. Drive continuous improvement and risk management using structured problem‑solving, Lean/6S practices, metrics, and quality risk management (ICH Q9), while maintaining flexibility to support off‑shift, weekend, or on‑call operational needs. Other duties as assigned by management. The Candidate Master's degree in a scientific, engineering, or biotechnology field with 6+ years' experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related) OR Bachelor's degree in a scientific, engineering, or biotechnology field with 8-10+ years' experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related). 5+ years of progressive leadership and direct management experience. Experience leading supervisors and/or shift teams preferred. Demonstrable leadership experience at Catalent (