Reagent Manufacturing Associate

  • 505 Penobscot Dr, Redwood City, CA 94063, USA
  • Full-time

Company Description

Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time and identifies associated treatment options. The recent introduction of groundbreaking analytical tools, including our Tumor Response Map and a mobile-enabled physician portal, further advance Guardant Health's momentum.  We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.


Job Description

SUMMARY

The Reagent Manufacturing Associate is responsible for manufacturing reagents, assembling kits, and qualification of assigned reagents used in Clinical Operations according to Standard Operating Procedures and documenting events following current Good Documentation Practices.

In addition, the Reagent Manufacturing Associate provides support to the Quality Control and Research Operations team. Which may include but not limited to performing manual extraction of plasma samples, assisting in assay set up under the supervision of a licensed professional, participate in trouble shooting investigations, weekly/monthly laboratory and equipment maintenance, and data entry and verification.

The Reagent Manufacturing Associate will interact with multiple teams including the Clinical Operations, Warehouse, Supply Chain, Quality Control, Quality, Research Operations, Reporting, Technology Development, and Process Engineering team.

The nature of the work requires manual and repetitive movement, excellent attention to detail, effective written and verbal communication skills, the ability to multi-task, be flexible with tasks and schedules, and the ability to work independently in a team environment.

 DUTIES

Manufacture reagents, assemble kits, and qualify assigned reagents supporting the Guardant360 test and ongoing projects. Perform weekly and monthly laboratory and equipment maintenance. Perform clerical work and maintain Reagent Manufacturing and Quality Control documents as necessary. Assist with managing and ensuring sufficient inventory of reagents used in the Reagent Manufacturing, Quality Control, and Clinical Operations Laboratories.  Coordinate reagent qualification activities with Clinical Operations personnel as necessary. Assist with reviewing and completing reagent qualification records.

Troubleshoot reagents when reagents do not pass qualification and ensure reagents are labeled and quarantined appropriately.

Participate in interdepartmental activities with Supply Chain, Clinical Operations and Quality to ensure qualified reagents for the Guardant360 test are available for use at all times. 

Assist with reagent stability related activities.

Assist in the update and development of Reagent Manufacturing Forms and SOPs pertaining to reagent manufacturing and qualification.

Communicate professionally and effectively with both internal and external personnel.

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

Adhere to our Quality System Management program.

Perform other miscellaneous laboratory duties as assigned and assist others as needed.



Qualifications

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

Previous GMP laboratory work experience preferred.

Ability to proactively communicate consistently, clearly, and honestly with internal employees, managers and customers as needed.

Possess meticulous attention to detail.

Able to work independently in a team environment.

Strong computing skills.

Able to integrate and apply feedback in a professional manner.

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 (Generally laboratory and Client Services employees only)

Repetitive manual pipetting may be necessary.

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



Additional Information

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

This description is used as a guideline for major duties. The company reserves the right to change or assign additional duties as needed.