The Cell Therapy Processing Specialist I will receive on the job training in order to perform 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. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. PRIMARY DUTIES AND RESPONSIBILITIES: 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 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 and evaluate problems related to product preparation, including issues with instrumentation, reagents, and documentation. Appropriately communicates outcomes, including escalating problems to supervisors and managers.
- Perform environmental monitoring of work area and laboratory.
- Participate in validations of new procedures, including working with vendors/trial sponsors
- Upgrade job skills to stay relevant and to progress in field.
?? ?? ?? Equipment - Perform preventative 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/equipment.
?? QA/Regulatory Duties and Responsibilities - Work within the cGMP and cGTP guidelines and adhere to all regulatory standards within the Cell Manipulation Core Facility, including:
- recognize and report deviations from standard operating procedures,
- initiate and document corrective actions when required.
?? 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.
- Knowledge of clinical Good Clinical Practice /research cGMP, cGTP.
- Knowledge of lab safety and infection control.
- Familiarity with operation & performance of basic lab equipment, e.g., centrifuge, microscopes, programmable freezers, etc.
MINIMUM JOB QUALIFICATIONS: Minimum Education: ??BS/BA in a Biological Science, medical technology environment or related field required. Minimum Experience: ??Some experience in a clinical laboratory setting preferred but not required. 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 groups as protected by law. |
