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Work Shift
Day
Work Day(s)
Monday-Friday
Shift Start Time
Variable
Shift End Time
Variable
Worker Sub-Type
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.
Job Description
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.
Experience
- 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
Preferred Qualifications
- Six Sigma Green or Black belt
- GMP Laboratory Control Professionals Certification or GMPCP Certified Professional
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
- 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 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.
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.
Primary Location Address
2220 North Druid Hills Road
Job Family
Director/Senior Director
