ASSISTANT LABORATORY SUPERVISOR
- Boston, MA
Cambridge Biomedical is a contract laboratory service organization that works with biotechnology, pharmaceutical and reference laboratories. We specialize in custom assay development, qualification and validation. Assays are performed in our CLIA / CAP accredited laboratory. Testing capabilities include clinical trial, diagnostic, and biosafety testing. Cambridge Biomedical offers a wide variety of analytical technologies in microbiology, immunology, molecular biology and clinical chemistry including HPLC, ELISA, and RIA, Cell Based Assays, Cell Culture, RT PCR, Colorimetric Assays and Spectroscopy. We are experts at solving assay development problems.
Cambridge Biomedical is seeking a technically skilled and highly motivated Assistant Laboratory Supervisor to provide technical support to staff performing moderate to high complexity testing of esoteric assays. As a member of our team you will be responsible for:
- Cross-training laboratory staff on various testing platforms ensuring competency
- Cross-validating assays on replicate instruments and/or methods
- Coordinating the proficiency testing program for the clinical laboratory
- Overseeing the validation and implementation of new laboratory assays
- Providing technical assistance to lab technicians and scientists as needed to troubleshoot and resolve assay performance problems and to improve the performance of assays and the clinical laboratory
- Serving as technical consultant with internal sales staff and external clients as needed to improve Cambridge Biomedical’s competitive profile
- Working with management to ensure that all facets of people, equipment, documentation, and procedures are compliant to all required regulatory agencies
- Assisting in selecting the test methodology that is appropriate for the clinical use of the test results
- Ensuring the completion of deliverables and adherence to timelines; tracks milestones and timelines across assigned projects, recommend alterations when necessary to meet expectations of clients; analyze and resolve issues that have the potential to jeopardize performance and/or ability to meet agreed upon deliverables.
- Supporting the Quality Assurance Department to ensure all necessary technical training and records are in compliance and Standard Operating Procedures are being followed
- Ensuring that all SOPs, procedures, and documents are current
- Troubleshooting complex chemistry assays including HPLC.
Position requires a BS degree in medical technology or related life science and 3 or more years of combined experience managing a clinical and/or diagnostic laboratory performing highly complex assays. Position requires national certification as a medical technologist (ASCP) or clinical laboratory scientist. The incumbent must fill the educational, experience, and certification requirements of 42CFR part 493.1461 and 21 CFR part 58 as most recently posted in the federal register. To perform this job successfully, the incumbent will:
- Have the ability to combine ingenuity and logic to the solution of problems, and foresight to confer with research and development scientists for design modifications and improvements.
- Be capable of providing employee and/or customer training and technology transfer.
- Maintain knowledge of GLP/CAP/CLIA regulations.
- Have excellent analytical, problem solving and decision making skills to manage and resolve highly complex science/technology issues