Senior Technical Director, GMP Facility- Winship Cancer Institute jobs in United States
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Emory University · 3 hours ago

Senior Technical Director, GMP Facility- 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. The Senior Technical Director, GMP Facility position is responsible for the daily operations and management of the Emory Cellular and Immunotherapy core, overseeing cellular therapy initiatives and ensuring compliance with good manufacturing practices.

E-LearningEducationHealth Care
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H1B Sponsor Likelynote

Responsibilities

Leads activities within the Emory ExCITE cell manufacturing laboratory
Responsible for all administrative operations, quality assurance and development and implementation of cell-processing and viral vector production procedures within the laboratories, including compliance with applicable regulating bodies
Works closely with members of Winship Cancer Institute and School of Medicine faculty to produce cellular and viral immunotherapy products for use in IND enabling studies and in early phase clinical trials
Exercises primary authority over the conduct of strategic research projects that seek services through the Facility including protocol development and adherence, human subjects, personnel management and budget oversight
Functions as a key programmatic liaison with sponsors, national partners, collaborators and internal investigators to advance cellular therapy research at Emory
Serves as primary internal liaison between all partners and Emory Healthcare to plan and implement appropriate cellular and viral immunotherapy study budgets and funds flow to support the advancement of cellular therapy treatment at Emory
Investigates, determines, establishes and oversees data use policies and administers and enforces adherence to established policies
Oversees construction/renovation of manufacturing spaces
Maintains a safe and compliant GMP environment adhering to GMP and University EHS standards
Ensures capacity and capabilities of the facility meets the needs of the Cancer Center/Clients
Coordinates with regulatory staff and hospital staff to meet patient needs
Authors/revises CMC sections as part of IND submission
Provides data and CMC updates for FDA annual reports
Ensures manufacturing is production ready upon IND approval
Develops and manages annual Facility budget
Interfaces with PIs to develop projects from research to clinical scale
Assigns team members to project manage upcoming trials and/or projects
Builds relationships with protocol PIs
Oversees creation of a training curriculum/plan for all team members
May assist investigators in grant and other funding applications as necessary and appropriate
With approval of the Scientific Director, may have their own research projects and/or have full responsibilities for specific areas of a program and may serve as the principal investigator on grant proposals
Performs related responsibilities as required

Qualification

GMP facility experienceCellular therapies researchLeadership experienceMolecular biologyImmunologySupervisory experienceBudget managementTraining curriculum developmentProject management

Required

PhD in immunology, molecular biology, molecular genetics, cell biology, or related field and ten years of professional level leadership experience in a technical or research lab which includes cellular therapies research
Laboratory experience in a GMP facility and supervisory experience required

Company

Emory University

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Emory University is an institute of higher learning and a private research university.

H1B Sponsorship

Emory University has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (417)
2024 (370)
2023 (308)
2022 (266)
2021 (164)
2020 (162)

Funding

Current Stage
Late Stage
Total Funding
$719.87M
Key Investors
GettyNational Institutes of HealthHyundai Hope On Wheels
2025-08-20Grant· $0.28M
2024-11-13Grant· $15M
2024-08-28Grant· $0.4M

Leadership Team

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Claire E Sterk
President Emerita and Charles Howard Candler Professor of Public Health
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Gregory Fenves
Chancellor
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