Supervisor, GMP Cell Manufacturing- Winship Cancer Institute

Emory University•Atlanta, GA

7d•Onsite

About The Position

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.

Requirements

Bachelors degree in biology or related field and three years GMP manufacturing experience required.
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.

Nice To Haves

Experience with human cell culture, nucleic acid manipulation (sequencing, RNA, DNA, extraction etc.) preferred.
Certification as a Medical Technologist
Masters degree in related field

Responsibilities

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.
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.
Involved in patient infusions, if requested.
Operate with a higher level of independence and will also support more complex work in the lab.
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.
Processes patient blood samples for product manufacture with required medical clearance (HEP vaccination, etc) to perform as required by ESHO.
Performs related responsibilities as required.