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 Supervisor is responsible for overseeing the daily operations of the Reagent Manufacturing department and for providing general supervision of personnel. The Reagent Manufacturing Supervisor is responsible for providing management of the manufacturing of reagents, assembling of kits, and qualification of assigned reagents. The Reagent Manufacturing Supervisor follows Good Manufacturing Practices (GMP) and documents events following current Good Documentation Practices (GDP). The Reagent Manufacturing Supervisor must also act as a liaison between Clinical Operations, Reagent Quality Control and Warehouse.

The Reagent Manufacturing Supervisor will also be involved with troubleshooting, 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 excellent attention to detail, 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 team 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, QC forms, and equipment maintenance forms as assigned;
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 assay improvements, new assay configurations and validation;
Participate in the inspection preparation activities as needed;
Perform, review and document laboratory quality control procedures, as needed;
Maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties;
Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications;
Lead in the troubleshooting of manufactured reagents;
Lead in the revision and development of Reagent Manufacturing SOPs and forms;
Lead in interdepartmental activities with Clinical Operations, Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are available for use at all times;
Participate in the inspection preparation activities as needed;
Lead in the training of new and existing laboratory personnel on current and new procedures;
Lead in the introduction of manufacturing improvements or new manufacturing configurations;
Lead various projects or studies;
Lead in the development of the design and acceptance criteria for Reagent Manufacturing plans;
Lead and document interdepartmental training on Reagent Manufacturing changes or improvements;
Oversee manufacturing build schedules working closely with supply chain and reagent QC teams;
Oversee and document activities following cGMP, when applicable;
Lead in team meetings;
Provide updates to the Clinical Core Team regarding any issues;
Participate in quality assurance activities;
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;
Perform biennial review of Standard Operating Procedures; and
Report all concerns of test quality and/or safety to the Technical Supervisor, Laboratory Director or Safety Officer.

Qualifications

High School Diploma with 12 years of experience in related field; OR
Minimum of Associate degree or equivalent with 8 years of experience in related field; OR
Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred;
Previous laboratory work experience preferred;
Previous GMP laboratory work experience preferred;
Ability to proactively communicate consistently, clearly, and honestly;
Strong computing skills;
Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed;
Able to integrate and apply feedback in a professional manner; and
Ability to work 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;
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. 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/

This job is no longer accepting applications

See open jobs at Guardant Health.See open jobs similar to "Supervisor, Reagent Manufacturing PM shift (3:00pm-11:30pm)" Khosla Ventures.

See more open positions at Guardant Health

Powered by Getro.com

Privacy policy Cookie policy