Reagent Manufacturing Associate I

Job Description

Job Description

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

About the Role :

The Reagent Manufacturing Associate (RMA) I is responsible for manufacturing reagents, assembling kits, and qualification of assigned reagents following Good Manufacturing Practices and documenting events following current Good Documentation Practices.

Essential Duties and Responsibilities :

Manufacture reagents, assemble kits, and qualify assigned reagents according to SOP;

Document reagent manufacturing activities following cGMP;

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

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

Clean racks and other laboratory supplies;

Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications;

Perform clerical work and maintain Reagent Manufacturing and Quality Control documents as necessary;

Assist with managing and ensuring sufficient inventory of reagents in the laboratories of Clinical Operations;

Assist with troubleshooting of manufactured reagents;

Assist in the revision and development of reagent manufacturing SOPs and forms;

Participate 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;

Assist in the inspection preparation activities as needed;

Perform other duties as assigned; and

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

Qualifications

High School Diploma with 2 years of experience in related field; OR

Minimum of Associate degree or equivalent; OR

Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred;

Guardant Health Clinical Laboratory experience or equivalent high complexity and volume laboratory experience 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

Hybrid Work Model : At Guardant Health, we have 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.

For positions based in Palo Alto, CA or Redwood City, CA, the hourly range for this full-time position is $30.77 to $41.53 . The range does not include benefits and, if applicable, overtime, 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  Peopleteam@guardanthealth.com

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 /

Salary : $31 - $42