Director Cellular Therapies

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Work Shift

Day

Work Day(s)

Monday-Friday

Shift Start Time

Variable

Variable

Regular

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. We’re committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children’s.

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.

Experience

• 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

Preferred Qualifications

• 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.

Education

• Ph.D. in a biologic or scientific field

Certification Summary

• No professional certifications required

Knowledge, Skills, and Abilities

• 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

Job 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.

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.

2220 North Druid Hills Road

Director/Senior Director