Plasmid DNA Manufacturing Lead – GMP & Tech Transfer

Bionova Scientific, Inc.; The Woodlands (TX); Presencial; USD 110.000 - 130.000; Jornada completa

Descripción de la vacante

Bionova Scientific LLC in The Woodlands, TX is seeking a Manufacturing Manager to lead end-to-end plasmid DNA manufacturing operations, including USP, DSP, and supporting activities. You will ensure safe, compliant, on-time, and efficient execution of client programs aligned with batch records and quality requirements.

You will build and mentor the manufacturing team, enable technology transfer, and partner with QA/QC, PD, MSAT, and Supply Chain to meet client commitments.

Formación

• BS/BA in a life science or engineering field required; 7–10+ years GMP biologics experience preferred.
• Minimum 3–5 years of people leadership within a matrix organization.
• Hands-on GMP manufacturing leadership including plasmid DNA and microbiology processes.

Responsabilidades

• Lead end-to-end plasmid DNA manufacturing operations (USP, DSP, support activities).
• Own manufacturing readiness, documentation, deviations, CAPAs, and change controls.
• Develop and lead a multi-disciplinary manufacturing team across functions.
• Collaborate across PD, MSAT, QA/QC, Program Management, Supply Chain and clients.
• Ensure safety, quality, schedule adherence, and GMP compliance.

Conocimientos

People leadership

GMP knowledge

Manufacturing leadership

Cross-functional collaboration

Problem solving

Educación

BS in Biology, Chemical Engineering, Microbiology, Biochemistry, Biotechnology, or related

Herramientas

GMP documentation

Technology transfer

Descripción del empleo

Bionova Scientific LLC in The Woodlands, TX is seeking a Manufacturing Manager to lead end-to-end plasmid DNA manufacturing operations, including USP, DSP, and supporting activities. You will ensure safe, compliant, on-time, and efficient execution of client programs aligned with batch records and quality requirements.

You will build and mentor the manufacturing team, enable technology transfer, and partner with QA/QC, PD, MSAT, and Supply Chain to meet client commitments.