Director/ Head, GMP 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