Cell Processing Specialist

The Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) assists DF/HCC members in developing new cell-based therapies for patients with cancer who are enrolled in novel therapeutic clinical research protocols. It also supports clinical research studies designed to evaluate the safety and efficacy of these novel treatments. Please visit https://cmcf.dana-farber.org The Cell Therapy Processing Specialist II performs a variety of tasks to provide the highest quality products for patients receiving more than minimally manipulated cellular therapy products on clinical trials. These trials include Gene Therapy, Cancer Vaccines, Immuno-effector Cells including CAR-T cells, Induced Progenitor Cells (iPS), Mesenchymal Stromal Cells, Adoptive Immunotherapy and other innovative therapies. The Cell Therapy Processing Specialist II is competent in all routine processing procedures with the ability to troubleshoot and participate in complex processing. May serve as Project Lead on Cell Therapy Trial without complex processing. Work Location: 100% on-site at our Boston Campus in the Longwood Medical area. Scheduling Requirements: Full Time, 40 hours per week Weekend, evening, and on-call coverage will be required on a rotating basis. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Cell Processing Process more than minimally manipulated clinical human therapeutic cellular products by various methods using manual and/or automated aseptic technique in a regulated clean room environment according to standard operating procedures and applicable regulations. Achieve and maintain competency in routine and complex processing procedures, including: cell culture, including aseptic technique, cryopreservation/thawing, cell selection (Miltenyi CliniMACS), centrifugation and washing, manufacture gene manipulated products using semi-automated platform, labeling and transportation. Review and evaluate test results for acceptability including automated and manual cell counts, viability results, flow cytometry histograms, sterility testing results. Accurately enter and maintain records of procedures and enter data, both manually and on electronic data capture systems. Identify, evaluate, and troubleshoot or correct problems related to product preparation, including issues with instrumentation, reagents, and documentation. Appropriately communicate outcomes, including escalating problems to supervisors and managers. Perform environmental monitoring of work area and laboratory. Assists in validation studies, including implementation, of new procedures and working with vendors/trial sponsors. Serve as project lead for at least one cell therapy trial, not requiring complex processing. Write and review Standard Operating Procedures. Upgrade job skills to stay relevant and to progress in field. Equipment Perform preventive and corrective maintenance of equipment and instrumentation. Identify the need for repair or service, as required. Respond to REES alarm system alerts and document corrective actions appropriately. Participate in validation of new instruments, including collaborating with development of SOPs and other documentation. QA/Regulatory Duties and Responsibilities Work within the cGMP and cGTP guidelines and adhere to all regulatory standards within the Cell Manipulation Core Facility recognize and report deviations from standard operating procedures, Initiate and document corrective actions when required. Training Participate in training of new Specialists and assists management to assess competency. Minimum Education: BS/BA in a Biological Science, Medical Technology or related field required. Minimum Experience: 2 years experience in a clinical laboratory setting or 1 year in a Cellular therapy or cGMP environment. Demonstrated Cell Processing Specialist I competency. KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: Capable of working in a fast-paced and rapidly changing environment and technology. Ability to communicate and interact effectively with team members and stakeholders. Capable of producing accurate results within strict time constraints. Ability to apply critical thinking skills and possess good judgment, problem solving skills, and attention to detail. Good analytical reasoning and ability to perform complex mathematical calculations using notation. Well versed in clinical Good Clinical Practice /research GMP, GTP, Good Laboratory Practice. Well versed in lab safety and infection control. Knowledge of operation & performance of basic lab equipment, e.g., centrifuge, microscopes, program freezers, etc., and the ability to troubleshoot problems. Ability to achieve level of subject matter expert when training on new processes. Demonstrate organizational skills and leadership qualities to serve as project lead for at least one Cell Therapy Trial. Able to identify process improvements and make recommendations to management. Actively pursues and participates in continuing education of minimum 5 hours of professional development annually. Ability to compile and/or present data for presentations to staff, project collaborators, or Trial Sponsors. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. EEOC Poster