Gmp Director

Chad The Heart of Africa Inc

Atlanta, Georgia, US
Gmp laboratory operations
Cell therapy product manufacturing
Fact compliance
This position will be responsible for leading the Good Manufacturing Practice (GMP) Laboratory operations team to manufacture cell therapy products for all cell therapy protocols at Children’s Healthcare of Atlanta, in compliance with the Foundation for the Accreditation of Cellular Therapy (FACT), current GMP requirements, and Food and Drug Administration (FDA) and State regulations, to ensure the safety of patients receiving these products

Job Summary

  • This position will be responsible for leading the Good Manufacturing Practice (GMP) Laboratory operations team to manufacture cell therapy products for all cell therapy protocols at Children’s Healthcare of Atlanta, in compliance with the Foundation for the Accreditation of Cellular Therapy (FACT), current GMP requirements, and Food and Drug Administration (FDA) and State regulations, to ensure the safety of patients receiving these products.
  • Ensures consistent, rigorous, and compliant manufacturing approaches are implemented for all gene and cell therapy products manufactured in the facility.
  • Children’s is one of the nation’s leading children’s hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow.

Matching Summary

This position will be responsible for leading the Good Manufacturing Practice (GMP) Laboratory operations team to manufacture cell therapy products for all cell therapy protocols at Children’s Healthcare of Atlanta, in compliance with the Foundation for the Accreditation of Cellular Therapy (FACT), current GMP requirements, and Food and Drug Administration (FDA) and State regulations, to ensure the safety of patients receiving these products.

Skills & Requirements

Must-have

  • GMP Laboratory operations
  • Cell therapy product manufacturing
  • FACT compliance
  • cGMP requirements
  • FDA and State regulations
  • CMC writing expertise

Nice-to-have

  • Continuous improvement culture
  • Develop strong technical talent
  • Sound and responsive decision-making
  • Diplomacy and patience

Key Requirements

  • Minimum of seven years in manufacturing GMP/clinical grade cell therapy products
  • Minimum of four years of management or supervisory experience
  • Experience working in a FACT accredited facility
  • Ph.D. in a biologic or scientific field
  • Six Sigma Green or Black belt (Preferred)
  • GMP Laboratory Control Professionals Certification or GMPCP Certified Professional (Preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter