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.Â 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.Â The Cell Therapy Processing Specialist II is competent in all routine processing procedures with ability to troubleshoot and participates in complex processing.Â May serve as Project Lead on one Cell Therapy Trial, without complex processing.
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:
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,
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.
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.
Participate in training of new Specialists and assists management to assess 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.
Minimum Education: Â BS/BA in a Biological Science, Medical Technology or related field required.
Minimum Experience: Â 2 yearsâ€™ experience in a clinical laboratory setting or 1 year in a Cellular therapy or cGMP environment.Â Demonstrated Cell Processing Specialist I competency.
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.
Internal Number: 2021-23898
About Dana-Farber Cancer Institute
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 under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.