Gmp Director

Children’s Healthcare of Atlanta

Atlanta, Georgia, USA
Not specified
Gmp cell therapy manufacturing
Fact accredited facility experience
Fda and state regulations compliance
Children’s Healthcare of Atlanta is seeking a Gmp Director to lead the operations of their GMP Laboratory, focusing on manufacturing cell therapy products in compliance with regulatory standards. The ideal candidate should have extensive experience in GMP manufacturing, strong leadership skills, and a robust scientific background

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.
  • Partners with the Medical Director, Marcus Center for Pediatric Cellular Therapy and the Vice President, Research & Academic Administration, to build a team providing GMP grade clinical products for experimental use.
  • Children’s Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.

Matching Summary

Match Score: 85

Children’s Healthcare of Atlanta is seeking a Gmp Director to lead the operations of their GMP Laboratory, focusing on manufacturing cell therapy products in compliance with regulatory standards. The ideal candidate should have extensive experience in GMP manufacturing, strong leadership skills, and a robust scientific background.

Skills & Requirements

Must-have

  • GMP cell therapy manufacturing
  • FACT accredited facility experience
  • FDA and State regulations compliance
  • CMC writing expertise
  • validation program management

Nice-to-have

  • continuous improvement culture
  • motivating others
  • diplomacy and patience
  • strategic direction

Key Requirements

  • Minimum of seven years in manufacturing GMP/clinical grade cell therapy products
  • Minimum of four years of management or supervisory experience
  • Ph.D. in a biologic or scientific field

Work Rights

Not specified

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