The Cell Manipulation Core Facility (CMCF) is seeking a hands on Clinical Laboratory Manager, who will oversee 8-10 direct reports. The Laboratory performs testing on both cell therapy donor samples and cellular products. The testign on HCT/P and investgational products includes cell counts, flow cytometry, PCR testing and purity assessments (sterility, endotoxin and Mycoplasma testing following UPS validated methods.) The position also requires the oversite and validation of LDTs (Laboratory Developed Tests) especially on our investigational products.
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.
This position is responsible for the day to day management of the Cell Therapy Testing Laboratory (CTTL) of the Cell Manipulation Core Facility (CMCF). This position works closely with CMCF leadership to coordinate the workflow and staffing within the laboratory to include both clinical and research related activities. Provides direction and is responsible for the technical and regulatory operation of the CTTL. This includes donor and product testing as well as environmental testing of the manufacturing facility, and development of new assays as needed. This position must ensure that quality assays are performed under the highest standards (CLIA compliant) of quality and in a timely manner while minimizing costs. Contributes to the institute’s mission through emphasis on quality, patient focused care, and planned change and cost containment. Primarily management/supervisory position. Is responsible for all facets of the CTTL laboratory operation and adherence to the applicable regulations and standards (CMS (CLIA), JC, FDA, cGMP, GTP, FACT, etc). Performs job specific responsibilities, demonstrate accountability for own actions and decisions. Participate in performance improvement and quality improvement activities. Utilizes resources efficiently and effectively, takes responsibility for own learning needs, brings ideas and concerns to Lab leadership and participates in department decision-making.
B.S. in Medical Technology or equivalent as defined by HCFA for General Laboratory Supervisor. MT(ASCP) certification strongly preferred. Minimum of 5 years of management / supervisory leadership experience. Extensive knowledge of flow cytometry, molecular diagnostics and immunohematology, working knowledge of microbiology and environmental testing. Must have extensive knowledge of FDA (cGMP & cGTP), AABB, CMS (CLIA), JC and DPH regulations and standards regarding laboratory procedures. MT (ASCP) certification preferred.
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.