Senior Technical Director, GMP Facility- Winship Cancer Institute

About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope Winship Cancer Institute of Emory University is Georgias only National Cancer Institute-designated Comprehensive Cancer Center a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching developing teaching and providing novel and highly effective ways to prevent detect diagnose treat and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patients needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of is Where Science Becomes Hope. For more information visit .

Winship is seeking qualified candidates for the Senior Technical Director GMP Facility position. Position details are as follows:

JOB DESCRIPTION:

• Senior Technical Director GMP Facility (Winship) is responsible for the daily operations and management of the Emory Cellular and Immunotherapy core (ExCITE) supported by Winship Cancer Institute and Emory University School of Medicine.
• Reporting to Winships Scientific Director of the Winship Cell Therapy Center operates as the functional leader of cellular therapy initiatives at Emory with advanced knowledge and expertise of laboratory and experimental platforms necessary to advance the development of human based cellular therapy products.
• Responsible for the development of standard operating procedures mentoring staff scientists supervision of research and/or regulatory staff oversight of services management of project pipelines and appropriate certification and/or accreditation of good manufacturing practice (GMP) capabilities.
• Oversight will include financial fiscal regulatory and quality aspects of the operations and require frequent cross-disciplinary administrative decision-making and forecasting with other key stakeholders in the Winship Cancer Institute and Emory University School of Medicine (SOM) where appropriate.
• Collaborates with academic faculty staff and trainees who are conducting cellular and viral immunotherapy research and activities related to IND preparation and submission and generation of GMP-quality products for conduct of clinical trials.
• Serves as a resource to investigators across the Winship Cancer Institute/SOM providing guidance related to technical feasibility and implementation of IND enabling studies and generation of GMP-quality cellular and viral therapy products.

Core responsibilities include but are not limited to the following:

• 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.

Business development functions to include but not limited to:

• 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.

MINIMUM QUALIFICATIONS:

• 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
• OR an equivalent combination or education training and experience.
• Laboratory experience in a GMP facility and supervisory experience required.