GMP Director

Children's Healthcare of Atlanta•Atlanta, GA

About The Position

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. Strong scientific background and hands-on experience in managing the operations of an academic of commercial cell therapy facility required.

Requirements

Minimum of seven years in manufacturing GMP/clinical grade cell therapy products
Minimum of four years of management or supervisory experience
Experience working in a FACT accredited facility
Advanced leadership and management skills
Strong written and verbal communications skills, including expertise in Chemistry, Manufacturing and Controls (CMC) writing
Experience successfully managing validation programs in support of GMP operations and writing and maintaining records in compliance with FDA requirements
Experience in project management with ability to organize, prioritize and complete multiple assignments independently
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
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

Nice To Haves

Six Sigma Green or Black belt
GMP Laboratory Control Professionals Certification or GMPCP Certified Professional

Responsibilities

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.
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.
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.
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 GMP Facility.
Create quality tracking metrics and dashboards.
Create staff performance metrics and dashboards.
Create a culture of continuous improvement for GMP Facility processes.
Provides coaching and mentoring of assigned team members to build a cohesive team capable of meeting project deliverables and timelines.
Helps advance the science of the Marcus Center for Pediatric Cell Therapy through leadership, strategic direction, guidance, coordination, and oversight of projects.