Sr. Manager, Manufacturing Operations - Plasmids
Core
Lead plasmid DNA (pDNA) manufacturing operations to ensure safe, compliant, and efficient execution of fermentation, harvest/lysis, purification, and fill/finish steps for gene therapy products.
Role type
Senior Manager, Manufacturing Operations (Biologics/Plasmids)
Builds
GMP-compliant plasmid DNA batches for Phase 3 through commercial production of AAV and viral vector-based therapies
Domain
Biopharmaceuticals / Gene Therapy / Plasmid Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing leadership, plasmid DNA process expertise (fermentation, purification, UF/DF), root-cause analysis, cross-functional collaboration, team coaching, regulatory compliance management, continuous improvement (Lean/6S)
Preferred skills
Experience leading supervisors/shift teams, familiarity with electronic manufacturing systems (MES/eBR, LIMS, CMMS), prior Catalent leadership program participation
Technologies
MES/eBR, LIMS, deviation/CAPA systems, CMMS
Responsibilities
Foster a strong Quality Culture emphasizing data integrity and right-first-time execution; Own day-to-day execution of plasmid DNA manufacturing activities ensuring adherence to SOPs and batch records; Drive production performance to meet schedule, yield, and cycle-time targets; Ensure manufacturing readiness each shift including materials, equipment, and personnel compliance; Provide visible, hands-on leadership on the manufacturing floor; Lead, coach, and develop a high-performing manufacturing team; Ensure personnel qualification and training compliance; Own and support manufacturing investigations and CAPAs; Partner with Engineering to maintain equipment reliability; Collaborate cross-functionally to execute production plans and resolve constraints; Ensure compliance with global GMP and regulatory requirements; Drive continuous improvement and risk management using structured problem-solving.
Seniority
Senior Manager, hands-on IC with team leadership
