Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Reagent Manufacturing PM Supervisor is responsible for overseeing the daily operations of the Reagent Manufacturing PM team and for providing general supervision of Reagent Manufacturing PM shift personnel. The Reagent Manufacturing PM Supervisor ensures that Good Manufacturing Practices (GMP) are followed and ensures compliance to Good Documentation Practices (GDP). The Reagent Manufacturing PM Supervisor will also act as a liaison between Supply Chain, Reagent Quality Control, and Warehouse and will be required to work fairly independently as there are limited cross functional resources available in the PM shift. 

The Reagent Manufacturing PM Supervisor will also be involved with troubleshooting failures, coaching and mentoring the manufacturing staff, building effective teams, managing projects and meeting project deliverables, and understanding and implementing manufacturing goals.  

The nature of the work requires acute attention to detail, understanding of regulatory compliance, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently in a PM shift environment. 

Essential Duties and Responsibilities: 

Provide day-to-day supervision of personnel; 

Oversee daily operations of the Reagent Manufacturing department including but not limited to scheduling, troubleshooting and resolving technical and non-technical issues; 

Perform administrative duties including but not limited to writing employee performance evaluations, writing and reviewing SOPs, protocols, and equipment maintenance forms as assigned; 

Perform NCR and CAPA investigations and address the discrepancies.  

Coach and mentor Reagent Manufacturing Associates including but not limited to providing guidance, constructive feedback, and assistance with the development of skills; 

Participate in introduction of reagent improvements, new reagent configurations and validations; 

Participate in Regulatory inspection activities as needed; 

Maintain sufficient inventory of material, supplies, and equipment in the laboratory for performance of duties; 

Lead in the troubleshooting of manufactured reagents; 

Lead in the revision and development of Reagent Manufacturing SOPs and forms; 

Lead in interdepartmental activities with Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are always available for use; 

Lead in the training of new and existing laboratory personnel on current and new procedures; 

Oversee and document activities following GDP 

Lead team meetings; 

Provide regular updates to management  

Effectively communicate technical information to technical and non-technical audiences; 

Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and communicating these to the appropriate management representatives as necessary for resolution;  

Perform equipment maintenance according to the laboratory’s standard operating procedures; 

Perform other laboratory duties as assigned; 

Ability to proactively communicate consistently, clearly, and honestly;  

Strong computing skills; 

Strong communication skills with the ability to maintain open communication with internal employees, managers and customers as needed; 

Ability to integrate and apply feedback in a professional manner; and 

Ability to work as part of a team. 

Perform biennial review of Standard Operating Procedures; and 

Report all concerns of test quality and/or safety to management, Laboratory Director, or Safety Officer. 

 

Qualifications

 

Bachelor's degree in scientific discipline with at least 8 years of experience in related field;   

And at least 4 years of experience in a high complexity and high-volume laboratory required; 

Previous GMP laboratory experience required; 

Previous supervisory experience preferred; 

Previous experience working on a PM shift preferred 

Work Environment

Hours and days may vary depending on operational needs; 

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

Exposure to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation; 

Repetitive manual pipetting may be necessary; and 

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

Additional Information

For positions based in Redwood City, CA, the base salary range for this full-time position is $136,000 to $183,600 plus 20% shift differential. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/