Medical Lab Scientist I – Cell Manipulation Core Facility

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.

The Randi and Brian Schwartz Family Cancer Immunotherapy and Cell Manipulation Facility at the Cancer Center at Beth Israel Deaconess Medical Center (BIDMC) is seeking a Medical Lab Scientist I to manufacture and/or process cellular immunotherapy products that are being administered to patients in the context of either standard of care therapy or clinical trials.

The Schwartz Family Facility brings together some of the brightest scientific minds in cancer immunotherapy and serves as a manufacturing center in which BIDMC’s physician-scientists develop immune-based treatments, including a promising experimental cancer vaccine, CART cell therapies, and other novel forms of cellular immunotherapy. The lab meets “Good Manufacturing Practice” (GMP) specifications. The Schwartz Family Facility is the state-of-the-art laboratory expands BIDMC’s research capacity with the ultimate goal of accelerating the delivery of new immunotherapies to patients with cancer.

Job Description:

Primary Responsibilities: 
1. Under the direction of a MLSII, lab manager manufacture/process more than minimally manipulated clinical human therapeutic cellular products inside an ISO Class 7 clean room of the GMP facility in accordance to established standard operating procedures, applicable regulations, and safety regulations. (essential) 

2. Performs routine testing, preparing of specimens, and evaluation of test results. Review and evaluate test results for acceptability including manual cell counts, viability results, immunohistochemistry staining and sterility testing results. Evaluates QC and calibration results for acceptability following established laboratory policies before reporting patient results. (essential) 

3. Contribute to publication of findings as needed. Participate in the preparation of written documents, including procedures, presentations, and proposals. Assist with orientation and training of new staff or students on lab 
procedures or techniques. Present information on research and laboratory work to others at laboratory meetings, journal clubs, and seminars. 

4. Ensures accuracy of test results. Evaluate test results, accurately enter and maintain records of procedures and enter data, both manually and on electronic data capture systems, and reports critical/urgent test results to providers according to established laboratory policies. Reviews own work to ensure that all work products are accurate, consistent with standards, and produced in a timely manner. Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs. (essential)  

5. Performs general lab maintenance as needed; clean room equipment sanitization, perform environmental monitoring of work area and laboratory. Participates in the evaluation of new methods, procedures and instruments and in the development of technical standard operating procedures under the direction of the laboratory leadership. Participate in validations of new procedures, including working with vendors/trial sponsors. (essential) 

6. Under general supervision performs and documents start-up, quality control, calibration, preventative maintenance and troubleshooting procedure on instruments and laboratory equipment per established laboratory protocols. Report facility and equipment failure and alarms to laboratory management. 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. Respond to all emergency calls promptly for critical equipment failure. (essential)  

7. Assists with inventory management to maintain adequate supplies for patients testing and processing. Maintain lab stock of reagents and processing supplies, manage safety records, and manage storeroom and 
ensure proper storage requirements are met and provide general lab support as needed. (essential) 

8. Applicant should be very organized, detail-oriented, intellectually motivated, and have excellent communication skills. Applicant will be involved in a defined research project with collaborative, team-oriented supervision. Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success. 

9. Participate in mandatory and voluntary continuing education to stay current with developments in the field of laboratory medicine. Completes all required competency assessments including the running and resulting 
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