Supervisor, Good Manufacturing Practices Virus Manufacturing - Winship Cancer Institute
About The Position
Manufacturing involves hands-on execution of viral vector production (Retrovirus and/or, Lentivirus) in a cleanroom under Good Manufacturing Practices (GMP), focusing on cell culture, purification, documentation (SOPs, Batch Records), equipment management, troubleshooting deviations, and ensuring quality and regulatory compliance for clinical therapies. Supports upstream/downstream processes, data reviews and tech transfers. Collaborates with cross-functional teams to scale up processes for gene/cell therapy products. Executes manufacturing of viral vectors following SOPs, batch records, and quality systems (QMS). Oversees generation of GMP master cell banking and virus manufacturing to include in-process testing of cell banks and virus lots. Manages safety testing for MCB and virus lots. Maintains virus inventory and stability schedules for manufactured cells and virus and manage all safety testing for manufactured virus-related products. Performs hands-on tasks in upstream (cell culture, transfection) and/or downstream (purification, filtration) operations. Authors, reviews, and maintains GMP documents (SOPs, Batch Records), ensuring Good Documentation Practices (GDP) and ALCOA principles. Support tech transfer, optimize processes, and contribute to new technology implementation. Operates, calibrates, cleans, and maintains virus specific manufacturing equipment within the GMP environment. Works with QA, QC, Technical Development, and clients, presenting data and updates. Trains and leads other team members in the manufacture of cell banks and virus. Performs related responsibilities as required.
Requirements
- Bachelor's degree in Biology, Biochemistry, Molecular Biology or a related field and seven years experience in a GMP manufacturing facility producing master cell banks and viruses or an equivalent combination of education and experience.
- Demonstrated ability to establish and implement virus manufacturing schema.
- Hands-on experience in cell/gene therapy manufacturing, viral vector production, chromatography, filtration.
- Strong knowledge of FDA/GMP regulations, quality systems (SOPs, validation, audits).
- Strong understanding of GMP, regulatory requirements, process development, and data analysis.
- Detail-oriented, strong problem-solving, excellent communication, ability to work in a cleanroom, and handle hazardous materials.
Responsibilities
- Hands-on execution of viral vector production (Retrovirus and/or, Lentivirus) in a cleanroom under Good Manufacturing Practices (GMP)
- Focusing on cell culture, purification, documentation (SOPs, Batch Records), equipment management, troubleshooting deviations, and ensuring quality and regulatory compliance for clinical therapies.
- Supports upstream/downstream processes, data reviews and tech transfers.
- Collaborates with cross-functional teams to scale up processes for gene/cell therapy products.
- Executes manufacturing of viral vectors following SOPs, batch records, and quality systems (QMS).
- Oversees generation of GMP master cell banking and virus manufacturing to include in-process testing of cell banks and virus lots.
- Manages safety testing for MCB and virus lots.
- Maintains virus inventory and stability schedules for manufactured cells and virus and manage all safety testing for manufactured virus-related products.
- Performs hands-on tasks in upstream (cell culture, transfection) and/or downstream (purification, filtration) operations.
- Authors, reviews, and maintains GMP documents (SOPs, Batch Records), ensuring Good Documentation Practices (GDP) and ALCOA principles.
- Support tech transfer, optimize processes, and contribute to new technology implementation.
- Operates, calibrates, cleans, and maintains virus specific manufacturing equipment within the GMP environment.
- Works with QA, QC, Technical Development, and clients, presenting data and updates.
- Trains and leads other team members in the manufacture of cell banks and virus.
- Performs related responsibilities as required.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
