Reagent Manufacturing Associate (PM Shift)

Guardant Health•Redwood City, CA

18h•Hybrid

About The Position

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. This role is responsible for manufacturing reagents, assembling kits, and qualifying assigned reagents according to SOP, documenting all activities following cGMP, and performing equipment maintenance. The associate will also maintain inventory, clean laboratory supplies, and document corrective actions. Additionally, this role involves clerical work, managing reagent inventory in Clinical Operations laboratories, assisting with troubleshooting manufactured reagents, and contributing to the revision and development of SOPs and forms. Collaboration with interdepartmental teams is crucial to ensure qualified reagents are available at all times, and assistance with inspection preparation may be required. The associate must report any concerns regarding test quality or safety to the appropriate personnel.

Requirements

High School Diploma with 4 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
Ability to work as part of a team

Nice To Haves

Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field
Guardant Health Clinical Laboratory experience or equivalent high complexity and volume laboratory experience
Previous laboratory work experience
Previous GMP laboratory work experience

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