Manufacturing Manager, Plasmid DNA GMP Operations

Asahi Kasei Bioprocess America, Inc.; United States; On-site; USD 110,000 - 130,000; Full time

Job summary

Bionova Scientific LLC, part of the Asahi Kasei Group, seeks a Manufacturing Manager to lead end-to-end plasmid DNA manufacturing operations, including upstream, downstream, and support activities. You will ensure GMP-compliant, on-time execution of programs and partner across departments to drive technology transfer and manufacturing readiness.

This hands-on leadership role requires deep technical knowledge of plasmid DNA manufacturing and strong people management, scheduling, and day-to-day

Qualifications

• BS or MS in Biology, Chemical Engineering, Microbiology, Biochemistry, Biotechnology, or related scientific/engineering discipline.
• Demonstrated hands-on GMP manufacturing experience.
• Minimum 10+ years of relevant industry experience (BS) or 7+ years (MS).
• Strong understanding of end-to-end microbial/plasmid DNA manufacturing and related unit operations.
• Experience leading cross-functional teams and managing multiple client programs.

Responsibilities

• Lead plasmid DNA manufacturing operations (USP, DSP, etc.) and ensure GMP compliance.
• Provide day-to-day leadership and staffing to meet schedules and client commitments.
• Oversee deviations, CAPAs, change controls, investigations, and root-cause analysis.
• Collaborate with QA, QC, PD, MSAT, and other functions to ensure readiness and risk mitigation.
• Report manufacturing readiness and performance metrics to leadership.

Skills

Leadership

GMP knowledge

Biologics manufacturing

Cross-functional collaboration

Problem solving

Project management

Education

BS in Biology

MS in Biotechnology / related field

Job description

Bionova Scientific LLC, part of the Asahi Kasei Group, seeks a Manufacturing Manager to lead end-to-end plasmid DNA manufacturing operations, including upstream, downstream, and support activities. You will ensure GMP-compliant, on-time execution of programs and partner across departments to drive technology transfer and manufacturing readiness.

This hands-on leadership role requires deep technical knowledge of plasmid DNA manufacturing and strong people management, scheduling, and day-to-day