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Molecular Technical Supervisor
  • Location: Raleigh, NC
  • Type: Direct Hire
  • Job #14534

About Us

Glympse Bio is pioneering the development of synthetic biomarkers – biochemical sensors developed using breakthroughs in science, engineering, medicine and artificial intelligence – that are engineered to be tunable to a range of diseases and offer earlier measures of response to disease and treatment. Our breakthrough technology measures protein activity from a blood draw to revolutionize disease diagnosis and monitoring. We are building a novel biomarker technology platform from the ground up, laying the foundation for innovative diagnostics which combines nanotechnology with AI to improve the lives of potentially millions of patients worldwide.

 

We are a vibrant and dedicated team working at the forefront of scientific discovery and clinical development. We are agile, resilient, and creative problem solvers. We are committed to bringing the best products to patients and at Glympse you will have the opportunity to work alongside a high functioning, interdisciplinary and collaborative team to develop an entirely new diagnostic modality.

 

Position Summary

We are looking for an exceptional lab supervisor to oversee the build and lead operations for our CLIA lab. You will manage a small team of direct reports, oversee patient sample testing, equipment maintenance, reagent and sample preparation in addition to other tasks in a complex clinical diagnostic laboratory. The Technical Supervisor will work closely with Quality Assurance to set up the CLIA laboratory, establish its Quality Management System, and lead the lab through successful audits and accreditation. This role is a key decision maker within Glympse R&D leadership and is a highly trusted team member for all laboratory personnel. This position will give the ideal candidate an opportunity to be a part of creating and building a lab from the ground up. You will be well supported by the existing organization with access to all the resources you will need to be successful. You will have the opportunity to build something exciting, hire a fantastic team, and lay the foundation for an innovative diagnostic which combines nanotechnology with AI to improve the lives of potentially millions of patients worldwide with a new groundbreaking new diagnostic tool.

 

 

Responsibilities

· Set up and manage laboratory and processes to ensure day-to-day operations follow internal standard operating procedures and regulatory standards of CLIA and CAP.

· Manage laboratory personnel by preparing schedules, providing guidance and direction.

· Work closely with Product Development team to transfer laboratory methods between sites.

· Evaluate and implement instrumentation, analytical methods, and laboratory procedures.

· Contribute to the development and maintenance of technical and analytical standards for method evaluation and quality improvement initiatives.

· Provide day-to-day technical leadership and act as operational decision maker on tactical issues.

· Provide training, competency evaluation, protocol compliance management and annual proficiency benchmarking of all CLIA laboratory personnel.

· Perform testing according to established standard operating procedures.

· Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed.

· Track samples progress and respond to sample progress inquiries.

· Support all operational aspects of quality assurance and quality control.

· Investigate and problem solve laboratory and department incidents, including driving the process forward, review and/or write non-conformance reports, deviations, CAPAs, and incident reports as needed in compliance with QMS system.

· Contribute to maintenance of equipment and other technical resources.

· Collaborate with internal teams, vendors, and others as needed to resolve issues, maintain ongoing functionality and document service, project management and repair work.

· Assist in preparing for, performing and responding to internal and external audits as well as any other inspections.

· Represent laboratory operations department at cross functional meetings or to guests as needed.

· Demonstrate commitment to maintaining TAT objectives, quality, and continuous improvement.

· Participate on cross functional teams to coordinate troubleshooting, process improvements, and/or implement new workflows or products.

· Maintain flexibility to cover scheduling gaps as needed.

· Manage laboratory budget,?order supplies, including reagents and consumables, and perform inventory counts.

· Adapt and scale existing systems to support growth and innovation across the company.

· Other duties, as assigned.

 

Qualifications

· Bachelor's degree in Molecular Biology or related science and 10+ years of experience in molecular diagnostics, preferably in a start-up environment

· 4+ years of supervisory experience in a clinical molecular diagnostics laboratory

· Qualified as a Technical Supervisor for high complexity testing

· Proven experience in clinical molecular assay design, validation, and implementation under CAP

· Experience in LIMS management for clinical testing

· MB(ASCP) certification

· Detail-oriented, thorough and rigorous

· Proven success collaborating with interdisciplinary teams in a fast-paced environment

· Independently learn, understand, and utilize current and developing CLIA standards

· Highly adaptable and comfortable in an environment with dynamic priority demands

· Self-motivated and effective at managing multiple projects in parallel

· Strong oral, written, and presentation communications skills

· Thrives in a collaborative, dynamic and fast-paced work environment

 

The Ideal Candidate:

· Brings courage, character, humility, and energy to work every day

· Is motivated to improve the lives of the people they serve

· Is excited about what might be possible, sees problems as challenges to be overcome, and is driven by curiosity and creativity

· Is optimistic and committed to Glympse’s mission

 

 

EEO Disclosure:

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected

veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law.

 

#KW   Job ID #14534

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