Supervisor, Biospecimen Management

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012 Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care including screening to find cancer early monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information visitand follow the company onLinkedInX (Twitter)andFacebook.

Profile Summary:

The Biospecimen Management (BSM) Supervisor is responsible for the general supervision of BSM personnel and the daily operations of the BSM workflows which include clinical pharma research and validation sample types. The BSM Supervisor may also perform sample receipt accessioning plasma isolation and pooling and recording samples sent for laboratory addition the BSM Supervisor will be required to perform quality control and quality assurance procedures while complying with all applicable local state and federal laboratory requirements.

The nature of the work requires excellent attention to detail effective written and verbal communication skills the ability to learn how to operate and troubleshoot multiple digital platforms and being flexible with tasks and schedules. The BSM Supervisor must be able to lead and work with a team as well as work independently.

Essential Duties and Responsibilities:

Provide day-to-day supervision of BSM personnel

Responsible for the operation of the BSM pre-analytical laboratory including receiving accessioning and processing all incoming specimens

Responsible for monitoring laboratory performance including analyzing laboratory data and identifying areas for improvement

Coach and mentor Biorepository Associates and Specialists

Identify process improvement opportunities and present them to the Manager

Perform review and document laboratory quality control procedures

Operate and maintain laboratory equipment as needed

Recruit and train BSM staff

Ensure that personnel are qualified and competent to perform their duties and keep personnel files updated including training documentation and competency assessments

Represent BSM in cross-functional meetings

Maintain a productive operational relationship with the IT and Enterprise Software departments to communicate ongoing modification requests

Work closely with the Clinical Operations Supervisors Clinical Development Clinical Trials team and Client Services Department in developing efficiencies/processes between the functional areas to ensure that SOPs and best practices for each department are met

Perform administrative duties including but not limited to writing and reviewing employee performance evaluations SOPs protocols clinical trial sample tracking and equipment maintenance forms

Maintain stringent standards for quality; identify and report any issues which might adversely impact the quality of test results and/or employee safety

Responsible for ensuring that laboratory operations are conducted in a safe manner including implementing safety procedures and maintaining a safe work environment

Support department projects and goals

Document all corrective actions are taken when test systems deviate from the laboratorys established performance specifications

Assist with internal audits and inspection preparation as needed

Report all concerns of test quality and/or safety to a Manager or Safety Officer

Perform other miscellaneous duties as assigned

Qualifications:

Bachelor of Arts or Science in Biomedical Laboratory Science Clinical Science or related field preferred

At least 3 years of related experience within a clinical laboratory healthcare or in the biotechnology industry strongly preferred

Previous supervisory or management experience preferred

Demonstrate a high level of competency when assisting in the pre-analytical sample processing steps

Ability to pipette and perform basic laboratory functions

Ability to proactively communicate consistently clearly and honestly

Strong computer skills and experience with laboratory information management systems (LIMS) required

Strong communicator with ability to maintain open communication with internal employees managers and customers as needed

Ability to provide and receive feedback in a constructive manner

Strong analysis and problem solving skills

Ability to prepare and maintain records and logs

Ability to prioritize tasks and drive results with a high emphasis on quality

Ability to analyze and solve basic issues

Ability to work independently and as part of a team

Work Environment:

Hours and days may vary depending on operational needs.

Standing or sitting for long periods of time may be necessary.

May be exposed to hazardous materials blood specimens and instruments with moving parts heating or freezing elements and high-speed centrifugation.

Repetitive manual pipetting may be necessary.

Some lifting (up to 25 pounds) may be necessary.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.