Reagent Manufacturing Manager Jobs in California

Company Description

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. For more information, visitguardanthealth.comand follow the company onLinkedIn,X (Twitter)andFacebook.

Position Summary:

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 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.

AI & Digital Fluency

• Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has 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.