Supervisor, Good Manufacturing Practices Virus Manufacturing Winship Cancer Institute

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.

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:

• Bachelors 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 tasksaregenerallyrequired tobe performed in-person at an Emory University location.Remote workfrom homedayoptions may be grantedatdepartmentdiscretion.Emory reserves the right to changeremote workstatus with notice toemployee.

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 Veterans 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: (V) (TDD).

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