Supervisor, GMP Cell Manufacturing- Winship Cancer Institute at Emory University

Atlanta, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

08 May, 26

Salary

0.0

Posted On

07 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cell Culture, Immunology, Gene Modification, GMP Compliance, Team Leadership, Data Processing, Cryopreservation, Patient Infusions, Standard Operating Procedures, Medical Clearance, Communication Skills, Attention to Detail, Training, Protocol Development, Quality Assurance, Quality Control

Industry

Higher Education

Description

Discover Your Career at Emory University 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. Description About Winship Cancer Institute of Emory University Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s 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 patient’s 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 cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu. Winship is seeking qualified candidates for the Supervisor, GMP Cell Manufacturing position. Position details are as follows: JOB DESCRIPTION: Supervisor, GMP Cell Manufacturing will work in our state-of-the-art, good manufacturing practices (GMP) facility, manufacturing GMP cell culture products for the treatment of patients with cancer and other projects for manipulating human cells intended for the use in treating various diseases will be performed. Will be responsible for manufacturing virus-specific T-cell and tumor-specific T-cells according to GMP, using a range of standard operating procedures (SOPs) some of which involve gene modification, for example to manufacture CART-cells. An understanding of cell biology and immunology as well as experience in cell culture is preferred. Will be involved in patient infusions, if requested. Will operate with a higher level of independence and will also support more complex work in the lab. May oversee and support a team of junior technicians by assigning responsibilities, monitoring performance, and ensuring compliance with GMP and laboratory standards. Maintains professional and courteous relationships with other staff members. Performs therapeutic cell processing and cryopreservation for ExCITE shared resource. Tech transfer of new protocols/procedures from research to GMP. Orders all consumables for GMP cell manufacturing. Prepares drug products for patient administration. Manages room/product schedules. Oversees the work of GMP cell production technicians. Responsible for all training in GMP cell manufacturing. Develops, maintains, and improves computerized databases and electronic worksheets recording activities. Processes data and generates reports suitable to be inserted into patient files and QA/QC program. Assists with the training of new staff. Implements the transition of new cell processing technologies. Ensures that the laboratory is fully prepared and stocked to perform scheduled and emergency cell processing at all times. Leads in the preparation and writing of abstracts, reports, papers, and presentations on the activities of the cell processing group, if requested. Responsible for job related training. Writes deviation reports, incident reports and validation reports. Generates/creates/edits new manufacturing SOPs and forms. Attends GMP training webinars and job-related seminars and meetings as requested. Liaises with other groups involved in cell therapy studies, such as physicians, translational researchers, research coordinators, regulatory affairs staff, quality control and quality assurance staff as requested. Teamwork is crucial for this position; good communication skills are required. The cells cultured utilizing aseptic technique are for clinical use, so attention to detail is required. Liquid nitrogen tanks are used for cell cryopreservation frequently, biosafety cabinets and incubators are thoroughly cleaned monthly, therefore the ability to lift 15-20 lb. of weight and physical activity is required. Processes patient blood samples for product manufacture with required medical clearance (HEP vaccination, etc) to perform as required by ESHO. Occasionally work over the weekend or holidays may be required upon request and scheduling. Performs related responsibilities as required. MINIMUM QUALIFICATIONS: Bachelors degree in biology or related field and three years GMP manufacturing experience required. PREFERRED QUALIFICATIONS: Experience with human cell culture, nucleic acid manipulation (sequencing, RNA, DNA, extraction etc.) preferred. Certification as a Medical Technologist Masters degree in related field 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). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

Responsibilities

The Supervisor will oversee the manufacturing of GMP cell culture products and manage a team of technicians. Responsibilities include ensuring compliance with GMP standards, preparing drug products for patient administration, and maintaining laboratory readiness.