Director Cellular Therapies

Director/Senior Director of Cell Therapy Laboratory Operations

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Job Description

This position is responsible for leading the Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) Laboratory operations teams to support the manufacture and processing of cell therapy products across all protocols at Children's Healthcare of Atlanta. The role ensures full compliance with the Foundation for the Accreditation of Cellular Therapy (FACT), current GMP and GTP requirements, and all applicable Food and Drug Administration (FDA) and State regulations, with a primary focus on ensuring the safety, quality, and integrity of products administered to patients.

This leader oversees day-to-day laboratory operations, quality systems, regulatory readiness, and continuous process improvement across both GMP and GTP environments. A strong scientific background and hands-on experience managing operations within an academic or commercial cell therapy facility are required.

• Minimum of five years in manufacturing GMP/clinical grade cell therapy products
• Minimum of three years of management or supervisory experience
• Advanced leadership and management skills
• Strong written and verbal communications skills, including expertise in Chemistry, Manufacturing and Controls (CMC) writing
• Experience managing validation programs supporting GMP manufacturing and clinical laboratory testing and writing and maintaining records in compliance with FDA requirements
• Experience providing oversight or governance of cellular therapy clinical laboratories and/or translational research laboratories
• Demonstrated project management skills in regulated laboratory environments

• Six Sigma Green or Black belt
• GMP Laboratory Control Professionals Certification or GMPCP Certified Professional
• Experience working in a FACT accredited facility
• Experience leading multi-disciplinary laboratory teams (e.g., GMP manufacturing, cellular therapy clinical lab, and/or translational research labs) and coordinating activities across these functions to support clinical trials and patient care.

• Ph.D. in a biologic or scientific field

• Relevant experience in manufacturing GMP/Clinical grade MCB and WCB of various cells, MSCs, TIL, CAR-T cells, T-Reg cells, and Gamma-Delta T cells
• Experience in Vector plasmid, Adenovirus, Retrovirus, Gamma-Retrovirus and Lentivirus for cell and gene therapies
• Experience overseeing translational assay development, validation, and technology transfer into clinical or GMP laboratories
• Expertise in CMC writing and maintaining records in compliance with FDA requirements
• Record of successfully managing validation programs in support of GMP operations
• Knowledge and experience in the operation of an academic or commercial cell processing facility, including demonstrated education and experience in areas of hematopoietic progenitor cell transplantation principles and practices, MSCs, T-Regs, Gamma-Delta T cells, MCB and WCB of various cell types, TIL and CAR T expansion
• Knowledge and expertise of functional testing and assay development for quality control testing of the various cell therapies including, flow cytometry, gram staining, BacT/Alert, Endotoxin testing, Mycoplasma testing, ELISA, qPCR, VCN and RCR testing.
• Experience in the use of bioreactors and in process automation
• Experience in research interactions with cell therapies-based companies
• Strong leadership track record especially in the areas of leading in a global and matrixed environment, working cross functionally and developing strong technical talent
• Strong written and verbal communication skills
• Ability to organize, prioritize and complete multiple assignments independently
• Highly motivated self-starter who can motivate others
• Advanced leader with ability to create strong culture for continuous improvement
• Sound and responsive decision-making and problem-solving skills
• Excellent oral and written communication skills to convey complex information clearly to all levels
• Ability to act with diplomacy and patience while interacting with colleagues, including

• Partners with the Director of Operations, Medical Director, Marcus Center for Pediatric Cellular Therapy Scientific Director, and Research & Academic Administration, to build a team providing GMP grade clinical products for experimental use. Actively participates in workforce management for GMP facility staffing, study capacity management to ensure the appropriate flow of products required to meet study enrollment and timelines, and training and quality…