Director Cellular Therapies

Children's Healthcare of Atlanta•Atlanta, GA

2d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

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.

Responsibilities

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 assurance.
Leads laboratory managers and senior scientific staff across manufacturing, clinical, and translation laboratories
Collaborates with translational laboratory activities, including assay development and technology transfer
Maintains compliance with FACT regulations, current Good Manufacturing Practice (cGMP) requirements and FDA and State regulations, including the production of sterile drug products to ensure the safety of patients receiving those products.
Ensures consistent, rigorous, and compliant manufacturing approaches are implemented for all gene and cell therapy products manufactured in the facility.
Writes and maintains all policies, standard operating procedures, and batch process records for the GMP Facility.
Review, approve, and where appropriate align standard operating procedures and work instructions across GMP, Cellular Therapy Lab, and Translational research activities.
Manages the set-up and completion of complex manufacturing processes, including master cell bank (MCB) production, working cell bank (WCB) production, Mesenchymal Stromal Cells (MSCs), Gamma-Delta T cells, CAR-T cells, Tumor infiltrating Lymphocytes (TIL), DC vaccines and T-Regs.
Responsible for filing and maintaining the Facility’s Drug Master File (DMF) with the FDA.
Participates and plays an active role in all meetings with the FDA, including Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meetings, pre-IND meetings, and Type-A and Type-B meetings.
Performs FDA regulated manufacturing processes, including completion of documents and data required for reporting purposes.
Oversee the budgeting, staff management and general operations of the laboratory facilities.
Create quality tracking metrics and dashboards. Extends quality and performance metrics, where appropriate, to include key indicators from the Cellular Therapy Clinical Lab and Translational Lab (e.g., turnaround times, error rates, assay performance, and study milestones).
Create staff performance metrics and dashboards.
Create a culture of continuous improvement for laboratory Facility processes.
Provides leadership, coaching, and mentoring to laboratory leaders and staff across the GMP Facility, Cellular Therapy Clinical Lab, and Translational Lab (as applicable), fostering collaboration, shared best practices, and professional development.
Help advance the science of the Marcus Center for Pediatric Cell Therapy through leadership, strategic direction, guidance, coordination, and oversight of projects.
Facilitates translation of discoveries from the Translational Lab into GMP‑compliant manufacturing processes and clinical laboratory assays, supporting the full bench‑to‑bedside continuum of cell and gene therapy development.