Supervisor, Good Manufacturing Practices Virus Manufacturing - Winship Cancer Institute

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Description:

JOB DESCRIPTION:

• 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.

MINIMUM QUALIFICATIONS:

• 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.
• Essential Skills & Qualification: 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.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee. 

Additional Details:

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

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