<p>Overview</p> <p>The Cell Manipulation Core Facility (CMCF) at Dana-Farber is hiring for a Lead Cell Processing Specialist, SCT. The Lead Cell Processing Specialist performs a variety of tasks to provide the highest quality products for patients undergoing stem cell transplant and other cellular therapies. The Lead Cell Processing Specialist is competent in all procedures with the ability to troubleshoot. The Lead Cell Processing Specialist will assess and determine training competency and perform in-process final verification prior to standard of care product distribution. The Lead Cell Processing Specialist will assist management in day to day supervision of the lab and act as the Supervisor designee as required.</p> <p>Position is on-site full time, located at Longwood.</p> <p>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.</p> <p>Responsibilities</p> <p>Cell Processing</p> <ul> <li> <p>Process 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.</p> </li><li> <p>Achieve and maintain competency in routine procedures including:</p> </li><li> <p>cryopreservation/thawing,</p> </li><li> <p>centrifugation/washing,</p> </li><li> <p>handling of genetically modified cells,</p> </li><li> <p>labeling and transportation.</p> </li><li> <p>Perform more complex processing procedures, both automated and manual methods, with assistance:</p> </li><li> <p>cell selections/depletions,</p> </li><li> <p>protocol specific studies.</p> </li><li> <p>Review and evaluate test results for acceptability including automated and manual cell counts, viability results, flow cytometry histograms, sterility testing results.</p> </li><li> <p>Identify and escalate problems related to product processing and quality data of products. Appropriately communicate outcomes.</p> </li><li> <p>Lead in validation studies to include study design and implementation.</p> </li></ul> <p>Equipment</p> <ul> <li>Perform quality check and cleaning of equipment and instrumentation. Identify the need for repair or referral as required. Respond to REES alarm system alerts and document corrective action. Participate in validation of new instruments. </li><li>Work with vendors to introduce new technology to the laboratory and provide input. </li></ul> <p>QA/Regulatory Duties and Responsibilities</p> <ul> <li>Work within the cGMP and cGTP guidelines and adhere to all regulatory standards within the Cell Manipulation Core Facility. </li></ul> <p>Training</p> <ul> <li> <p>Assist Supervisor in review of records and compilation of required documents related to manufacturing.</p> </li><li> <p>Act as final in-process verifier.</p> </li><li> <p>Assume additional management, leadership or training responsibilities outside the daily scope of work for Cell Therapy Processing Specialists I and II:</p> </li><li> <p>assist QA in developing and operating a training program as a trainer or mentor,</p> </li><li> <p>assess training competency,</p> </li><li> <p>function as project lead for new technology implementation or clinical trial.</p> </li></ul> <p>Leadership</p> <ul> <li>Acts as Supervisor/Manager designee as applicable. Assists supervisor and manager in day-to-day supervision of staff in the laboratory. Mentors new members of the profession. </li></ul> <p>Qualifications</p> <p>Minimum Experience:</p> <p>Minimum of five years in a cellular therapy laboratory, including two years demonstrated leadership skills.</p> <p>Minimum Education:</p> <p>BS/BA in a Biological Science, Medical Technology or related field preferred.</p> <p>Knowledge, Skills and Abilities Required:</p> <ul> <li>Ability to independently perform complex selections and depletions along with all routine cell processing for all allogeneic and autologous products. </li><li>Ability to develop protocols associated with complex processing. </li><li>Ability to apply critical decision-making skills, apply good judgment and attention to detail. </li><li>Communicate effectively and professionally with other health care providers involved in the patient's care. </li><li>Ability to continually upgrade job skills. </li><li>Ability to work effectively, independently and as a member of a team. </li><li>Strong interpersonal and communication skills. </li><li>Capable of working in a fast-paced and rapidly changing environment. </li><li>Capable of producing accurate results within strict time constraints. </li><li>Ability to adapt to changing technology. </li><li>Ability to perform complex mathematical calculations using scientific notation. </li><li>Knowledge of lab safety and infection control; clinical/research GCP knowledge. </li><li>Familiarity with operation and performance of basic lab equipment, i.e., centrifuge, microscopes, program freezers, etc. </li><li>Demonstrates ability in problem solving, troubleshooting, and conflict resolution. </li><li>Requires a minimum of 15 hours of professional development annually. </li><li>Participates in organization wide activities such as committees, workgroups, etc. </li><li>Active membership, participation and leadership in national professional organization at the national level. </li><li>Demonstrates leadership in a professional organization preferred. </li></ul> <p>SUPERVISORY RESPONSIBILITIES:</p> <p>No direct reports; provides direction for Cell Therapy Processing Specialist I, II, and III for hands-on operation of the lab.</p> <p>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.</p> <p>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.</p> <p>EEOC Poster</p>