Cambridge, MA

Manager, Clinical Laboratory Operations

Seniority Level

Senior

Industry

Biotech/Pharma

Employment Type

Full-time

We are seeking an experienced Senior / Manager to join our growing clinical laboratory operations team in Cambridge. The successful candidate will work closely with the Laboratory Operations management team to support the operationalization of a new clinical lab in Cambridge and oversight of daily operations in accordance with regulatory guidelines.  This person will be accountable for supervising and mentoring lab personnel, providing technical guidance to resolve laboratory issues, working with senior management to assure goals are being met, and managing and developing workflows to maximize team potential.

Responsibilities

  • Oversight of workflow-focused teams (pre-analytical, immunoassay, sequencing) in a high complexity clinical molecular diagnostic laboratory performing laboratory developed tests and IVD kits
  • Responsible for daily supervision of work activities of testing personnel including compliance with SOPs and safety policies, priorities and scheduling, review of results to ensure successful sample processing
  • Ensure testing meets cost, turnaround time, quality and other critical product performance metrics required to deliver the best results and experience to our customers
  • Flexibility to cover supervisor and testing personnel scheduling gaps as needed and to be included in the on-call rotation for additional weekend and/or holidays
  • Partner with R&D and QA teams to establish and document objective analytical workflow performance criteria and associated operational requirements to satisfy CAP/CLIA and then FDA requirements
  • Support implementation of quality assessment and improvement initiatives including CMS-approved proficiency testing in Cambridge in accordance with Thrive’s quality management system and state and federal regulations
  • Support Cambridge internal and external audits as well as any other inspections
  • Support ongoing training and competency evaluation of workflow teams
  • Maintain familiarity with Thrive SOPs, practices, and applicable professional, federal, state, and local regulations, and ensure that the laboratory is compliant
  • Writes and reviews timely incident and non-conformance reports, deviations, and CAPAs as needed in compliance with Thrive’s QMS system. Supports root cause analysis and through implementation of solutions in partnership with R&D and Technology
  • Implement reagent procurement and QC per materials management policies
  • Support ongoing product improvements by providing objective feedback on existing workflows, evaluating revised workflows and prioritizing design transfer and deployment of revised workflows according to Thrive’s Design Change Control policies
  • Support the development and implementation of LIS, analytical pipelines, dashboards and other technology solutions

Qualifications

  • Master’s or Bachelor’s degree in relevant chemical, physical or biological field from an accredited college or university
  • 4+ years of relevant wet lab experience performing molecular biology or equivalent procedures in a CLIA/CAP/GxP/QSR lab
  • 2+ years of experience managing a team and a demonstrated ability to supervise, mentor, and train, in a production environment
  • Working knowledge of Good Laboratory Practices (GLP) and other relevant Federal and State regulatory agency standards such as CLIA
  • Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
  • Experience in high volume clinical laboratory running high complexity laboratory developed tests
  • Ability to bring innovative thinking and ideas to solve problems and improve any and all phases of laboratory operations
  • Comfortable in a fast-paced, dynamic team environment
  • Demonstrated leadership competencies such as decision making, influencing, conflict resolution and coaching. Excellent oral and written communication skills, and critical problem-solving abilities
  • Strong attention to detail and the ability to multi-task and adapt rapidly to changing priorities and tasks
  • Qualifies as Technical or General supervisor according to NYS regulations preferred
Are you qualified?

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