Manufacturing Manager, Plasmid DNA

About the role

The Manufacturing Manager leads end‑to‑end plasmid DNA manufacturing operations, overseeing upstream and downstream processes, ensuring safe, compliant and on‑time execution of client programs.

Key responsibilities

• Lead all plasmid DNA manufacturing activities, including upstream processing, harvest, clarification, downstream processing, formulation, filtration and related support tasks.
• Recruit, train, develop and manage a team of manufacturing scientists and associates, establishing performance expectations and development plans.
• Partner with Process Development, MSAT, Quality Assurance, Quality Control, Supply Chain and Engineering to ensure successful technology transfer, scale‑up and manufacturing readiness.
• Ensure compliance with GMP requirements, regulatory expectations and company quality systems, overseeing deviations, investigations, CAPAs and change controls.
• Maintain operational readiness of personnel, equipment, materials and documentation before each campaign and monitor manufacturing performance indicators.

Required profile

• BS or MS in a scientific or engineering discipline (Biology, Chemical Engineering, Microbiology, Biochemistry, Biotechnology) with at least 10 years of GMP biologics or plasmid DNA manufacturing experience (7 years with an MS).
• 3–5 years of people‑leadership experience in a matrix environment, demonstrating ability to build and lead manufacturing teams.
• Proven track record of executing technology transfers, scale‑ups and new facility start‑ups in a GMP setting.
• Strong problem‑solving skills and ability to manage multiple client programs and manufacturing priorities.

Required skills

• GMP manufacturing of plasmid DNA and microbial fermentation processes.
• Upstream processing, harvest/centrifugation, tangential flow filtration (TFF), chromatography, filtration and single‑use technologies.
• Preparation and review of GMP documentation: batch records, SOPs, deviations, investigations, CAPAs, change controls.
• Technology transfer, scale‑up, process implementation and equipment qualification.