Sr. Manager, Manufacturing Operations - Plasmids

Overview

Sr. Manager, Manufacturing Operations – Plasmids will oversee the safe, compliant, and efficient execution of plasmid DNA (pDNA) manufacturing operations. The role leads a team of manufacturing associates and supervisors, drives production performance, and ensures GMP compliance across the plasmid value stream.

• Own day‑to‑day execution of plasmid DNA manufacturing activities, ensuring adherence to batch records, SOPs, 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, and GMP documentation standards.
• Coach, develop, and manage a high‑performing manufacturing team, including onboarding, performance feedback, engagement, accountability, and effective shift coverage.
• Ensure personnel qualification and training compliance in partnership with Quality and Training.
• Own and support manufacturing investigations (deviations, nonconformances) and CAPAs, ensuring timely root‑cause analysis and cross‑functional alignment.
• Partner with Engineering and Facilities to maintain equipment reliability and availability, support PMs, calibrations, troubleshooting, validation, and readiness for new equipment or processes.
• Collaborate cross‑functionally to execute production plans, support technology transfers, and resolve constraints impacting delivery.
• Ensure compliance with global GMP and regulatory requirements (FDA 21
  
  CFR
  210/211, ICH Q‑series, EU Annex2, 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 (ICHQ9).
• Support off‑shift, weekend, or on‑call operational needs as required.

• Master’s degree in a scientific, engineering, or biotechnology field with 6+ years’ experience in GMP manufacturing operations within biologics/biopharmaceuticals, OR Bachelor’s degree with 8–10+ years’ experience.
• 5+ years of progressive leadership and direct management experience, preferably leading supervisors and shift teams.
• Demonstrable leadership experience at Catalent, including participation in leadership programs, may be considered in place of external experience.
• Familiarity with electronic manufacturing and quality systems (MES/e , LIMS, deviation/CAPA systems, CMMS) and ability to generate, analyze, and interpret production and quality metrics.
• Strong analytical, troubleshooting, and decision‑making skills under pressure, with experience in root‑cause analysis and continuous improvement initiatives.
• Strong understanding of plasmid DNA manufacturing processes (microbial fermentation, harvest/lysis, chromatographic purification, UF/DF, filtration) and controls to prevent contamination, mix‑ups, and quality risks.
• Effective communicator across technical and non‑technical audiences, able to work independently and collaboratively in cross‑functional teams.
• Proven ability to deliver results in a fast‑paced GMP environment, including flexibility to support off‑shift coverage, on‑call escalation, and periodic weekend work.

• Competitive salary range in Maryland: $165,000 – $185,000 plus eligible annual bonus.
• Medical, Dental, Vision, and 401(k) benefits from day one.
• 152 hours of PTO and 8 paid holidays.
• Career growth opportunities within an expanding team and cross‑functional exposure.

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, please contact Disabili