7+ years gmp cell therapy manufacturing experience
4+ years management or supervisory experience
Fact accredited facility experience required
This position leads the Good Manufacturing Practice (GMP) Laboratory operations team to manufacture cell therapy products in compliance with FACT, FDA, and State regulations
Job Summary
This position leads the Good Manufacturing Practice (GMP) Laboratory operations team to manufacture cell therapy products in compliance with FACT, FDA, and State regulations.
The role requires a strong scientific background with hands-on experience managing academic or commercial cell therapy facilities to ensure patient safety.
Candidates must demonstrate advanced leadership skills, including the ability to manage workforce, study capacity, and training while maintaining rigorous compliance standards.
Matching Summary
This position leads the Good Manufacturing Practice (GMP) Laboratory operations team to manufacture cell therapy products in compliance with FACT, FDA, and State regulations.
Skills & Requirements
Must-have
7+ years GMP cell therapy manufacturing experience
4+ years management or supervisory experience
FACT accredited facility experience required
Expertise in CMC writing and FDA record maintenance
Experience managing validation programs for GMP operations
Nice-to-have
Six Sigma Green or Black belt certification
GMPCP Certified Professional certification
Ph.D. in biologic or scientific field
Strong leadership in global matrixed environment
Ability to create culture of continuous improvement
Key Requirements
Minimum seven years in manufacturing GMP/clinical grade cell therapy products
Minimum four years of management or supervisory experience
Experience working in a FACT accredited facility
Advanced leadership and management skills
Expertise in Chemistry, Manufacturing and Controls (CMC) writing