Senior Manager, Reagent Manufacturing

• Oversee Reagent Manufacturing department and daily operations including build schedules inventory and resolving technical and non-technical issues;
• Perform administrative duties including hiring training employee performance evaluations writing and reviewing work instructions protocols forms and equipment maintenance forms as assigned;
• Coach and mentor Reagent Manufacturing Supervisors and Associates by providing guidance constructive feedback and assistance with the development of skills;
• Lead in interdepartmental activities with Clinical Operations Quality Assurance Quality Control Technology Development Engineering Bioinformatics and Supply Chain Management to ensure an uninterrupted supply of qualified reagents;
• Participate in assay improvements new assay configurations and validations by review of detailed work instructions and process maps for IVD reagent manufacturing and QC including procedures for reagent manufacturing and quality control testing BOMs process flow diagrams raw material specifications and protocols and reports for studies required to transfer reagent products into production;

• Participate in inspection preparation and inspections as needed;
• Maintain sufficient inventory of material supplies and equipment in the laboratory for performance of duties;
• Partner with the Supply Chain Management team to identify evaluate and manage material suppliers manufacturing equipment vendors and contract manufacturers;
• 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;

• Document all corrective actions taken when test systems deviate from the established performance specifications;
• Ensure timely and effective execution of relevant risk management activities including manufacturing process FMEAs and the resulting definition of required supplier controls and manufacturing process controls; and
• Coordinate with QA and the Engineering team to design plan document and conduct IQ/OQ/PQ for manufacturing and quality control testing equipment.

• Minimum Bachelors degree or equivalent in Biomedical Laboratory Science Clinical Science or related field preferred with 8 years of management experience in related field;
• Strong working knowledge of ISOCFR 820 and/or other applicable regulatory requirements for the manufacturing of medical devices
• Previous experience in leading a variety of essential activities including reagent qualification inventory management procedure writing inspection preparation process validation and investigation;
• Previous experience manufacturing in cGMP laboratory required;
• Previous involvement in design development documentation and validation of analytical/functional test methods for quality control.
• Experience with Process Validations and transferring of new manufacturing processes and associated risk management processes for medical in vitro diagnostic (IVD) products under ISO 13485 and/or FDA 21CFR820;
• Understanding of Next Generation Sequencing processes and automated workflows;
• Previous experience with direct management responsibilities including hiring professional development & training;
• Strong communicator with ability to maintain open communication with internal employees managers and customers as needed;
• Ability to prioritize and adapt to changing priorities while maintaining a high-quality standard;
• Ability to work in a fast-paced multidisciplinary and dynamic environment managing multiple activities simultaneously; and
• Ability to work as part of a team.

• 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.

Employee may be required to lift routine office supplies and use office 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 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

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

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.

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Senior Manager