GMP-Plasmid DNA Manufacturing Manager

Asahi Kasei Bioprocess America, Inc.; The Woodlands (TX); Vor Ort; USD 110.000 - 130.000; Vollzeit

Zusammenfassung

Bionova Scientific LLC is a rapidly growing biologics CDMO focused on plasmid DNA manufacturing. We seek a Manufacturing Manager to lead end-to-end operations, including USP, DSP, and support activities, ensuring safe, compliant, on-time execution of client programs.

The role requires hands-on GMP leadership, experience with tech transfer, and collaboration with PD, MSAT, QA/QC, Program Management, and Supply Chain to ensure manufacturing readiness and successful client outcomes.

Qualifikationen

• BS or MS in Biology, Chemical Engineering, Microbiology, Biochemistry, Biotechnology, or related field.
• Minimum 10+ years of GMP biologics/plasmid DNA experience with BS or 7+ years with MS.
• 3–5 years of people leadership in a matrix organization.
• Hands-on GMP manufacturing experience.
• Experience with tech transfer, scale-up and process implementation.
• Experience with new facility or laboratory start-up (preferred).
• Strong cross-functional collaboration and client-facing skills.
• Strong problem-solving and communication abilities.

Aufgaben

• Lead all plasmid DNA manufacturing activities, including USP, harvest, clarification, DSP, formulation, filtration, and related support.
• Recruit, train, and lead manufacturing scientists and associates; establish responsibilities and development plans.
• Ensure GMP compliance, batch records, deviations, investigations, CAPAs, and change controls.
• Partner with PD, MSAT, QA, QC, Supply Chain, and Program Management for technology transfer and readiness.
• Participate in client meetings, facility tours, and manufacturing readiness reviews.

Kenntnisse

GMP manufacturing

People leadership

Cross-functional

Technology transfer

Process scale-up

Documentation

Client-facing

Problem solving

Ausbildung

BS/MS in biology/engineering

Jobbeschreibung

Bionova Scientific LLC is a rapidly growing biologics CDMO focused on plasmid DNA manufacturing. We seek a Manufacturing Manager to lead end-to-end operations, including USP, DSP, and support activities, ensuring safe, compliant, on-time execution of client programs.

The role requires hands-on GMP leadership, experience with tech transfer, and collaboration with PD, MSAT, QA/QC, Program Management, and Supply Chain to ensure manufacturing readiness and successful client outcomes.