Director Cellular Therapies

About the role

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.

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.
• Reviews, approves, and where appropriate aligns 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.
• Oversees 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.

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

Qualifications

Ph.D. in a biologic or scientific field

Skills

• 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)
• Experience in Vector plasmid, Adenovirus, Retrovirus, Gamma-Retrovirus and Lentivirus for cell and gene therapies
• Expertise in CMC writing and maintaining records in compliance with FDA requirements
• Knowledge and experience in the operation of an academic or commercial cell processing facility
• 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

Benefits

No specific benefits mentioned in the job posting.

Pay

No specific pay information provided in the job posting.

Schedule

No specific schedule information provided in the job posting.