About BostonGene
BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision-making in the fight against cancer. Our unique solution continuously aggregates the latest cancer research and clinical information from around the world. BostonGene’s unique solution performs sophisticated analytics to aid clinicians in evaluating viable treatment options for each patient’s individual genetics, tumor and tumor microenvironment, clinical characteristics and disease profile. BostonGene’s mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies via sophisticated analytics and the integration of scientific and clinical knowledge.
Position Summary
The Director of Laboratory Operations is a critical member of the clinical team, overseeing all aspects of the day-to-day workings of BostonGene’s CLIA/CAP lab in Waltham, MA.
Responsibilities
- Manage all daily laboratory operations.
- Ensure regulatory compliance (MA, CLIA, CAP, NY) within all aspects of the clinical laboratory process, working closely with QA.
- Hire and train all clinical lab staff. Oversee competency and proficiency testing.
- Create and manage staffing schedules, covering 2 shifts and 7 days per week.
- Work closely with the senior lab staff to address issues in the lab as they arise, develop solutions to open challenges, and guide the overall direction of lab operations.
- Interface regularly with other departments including QA, R&D, Client Services, Sales, Bioinformatics, LIMS, and Report Coordination to ensure consistent and high-quality sample processing within published Turn-Around-Times.
- Owner of the clinical laboratory LIMS development.
- Owner of clinical laboratory Automation development.
- Communicate with all team members regarding logistical and administrative issues in the lab.
- Identify inefficiencies or opportunities for process improvement in the lab.
- Maintain and improve upon processes within the lab to increase efficiency, reduce TAT, improve quality, reduce costs, and increase throughput.
- Review and approve all laboratory documents including SOPs, Batch Record templates, and Forms.
- Represent the clinical lab in all audits and inspections.
Qualifications
- A minimum of 8 years of direct CLIA laboratory experience in a High Complexity lab is required.
- A Ph.D. in relevant biological science is required. MD Pathologist or board-certified physician is also acceptable.
- Previous experience as a CLIA Technical Supervisor desired.