Director, CAR T Manufacturing
Director/ Head, GMP Manufacturing
Location: Allendale, NJ (on-site)
EPM Scientific is working with an innovative, clinical-stage biotech company focused on advanced therapies to hire a GMP Manufacturing leader. This is a high-impact role supporting GMP production, quality, and compliance in a growing organization.
What you'll be doing:
- Oversee day-to-day GMP manufacturing operations, including scheduling, planning, and resource allocation
- Ensure compliance with cGMP, FDA, and global regulatory requirements across manufacturing activities
- Review and approve GMP documentation (SOPs, batch records, reports)
- Partner with QA on deviations, CAPAs, change controls, and audit readiness
- Lead and develop a growing manufacturing team, including hiring, training, and performance management
- Ensure production readiness across facilities, equipment, and materials (including maintenance and qualification activities)
- Collaborate cross-functionally with QA, technical operations, and external partners (CMOs)
- Support internal/external audits and drive follow-up actions
What they're looking for:
- Bachelor's degree in a scientific or engineering discipline (advanced degree a plus)
- Strong background in GMP manufacturing within biotech/pharma
- Prior leadership experience managing teams in a GMP environment
- Hands-on experience with biologics, cell therapy, or advanced therapy manufacturing preferred
- Technical experience with cell culture, viral transduction, or related processes is a plus
- Strong knowledge of quality systems (deviations, CAPA, change control, batch review)
- Comfortable working in a hands-on environment and supporting manufacturing operations as needed
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