Medical Lab Scientist I – Cell Manipulation Core Facility

About the role

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.

Responsibilities

• 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.
• 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.
• Contribute to publication of findings as needed.
• Participate in the preparation of written documents, including procedures, presentations, and proposals.
• Aid in the preparation 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.
• Ensure 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.
• 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.
• 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.
• 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.

Qualifications

• Bachelor's degree in Medical Laboratory, Life Sciences or Medical Technology required.
• Registration ASCP Registered preferred.
• 0-1 Years Related Work Experience Required.
• Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.

Preferred Qualifications

• Successful completion of a clinical laboratory medicine rotation, clinical practicum, or equivalent clinical laboratory experience.

Compensation

The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.