Supervisor, Reagent Manufacturing PM shift (3:00pm-11:30pm)

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

The Reagent Manufacturing PM Supervisor is responsible for overseeing the daily operations of the Reagent Manufacturing PM team and for providing general supervision of Reagent Manufacturing PM shift personnel. The Reagent Manufacturing PM Supervisor ensures that Good Manufacturing Practices (GMP) are followed and ensures compliance to Good Documentation Practices (GDP). The Reagent Manufacturing PM Supervisor will also act as a liaison between Supply Chain, Reagent Quality Control, and Warehouse and will be required to work fairly independently as there are limited cross functional resources available in the PM shift. 

The Reagent Manufacturing PM Supervisor will also be involved with troubleshooting failures, coaching and mentoring the manufacturing staff, building effective teams, managing projects and meeting project deliverables, and understanding and implementing manufacturing goals.  

The nature of the work requires acute attention to detail, understanding of regulatory compliance, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently in a PM shift environment. 

Essential Duties and Responsibilities: 

• Provide day-to-day supervision of personnel; 

• Oversee daily operations of the Reagent Manufacturing department including but not limited to scheduling, troubleshooting and resolving technical and non-technical issues; 

• Perform administrative duties including but not limited to writing employee performance evaluations, writing and reviewing SOPs, protocols, and equipment maintenance forms as assigned; 

• Perform NCR and CAPA investigations and address the discrepancies.  

• Coach and mentor Reagent Manufacturing Associates including but not limited to providing guidance, constructive feedback, and assistance with the development of skills; 

• Participate in introduction of reagent improvements, new reagent configurations and validations; 

• Participate in Regulatory inspection activities as needed; 

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

• Lead in the troubleshooting of manufactured reagents; 

• Lead in the revision and development of Reagent Manufacturing SOPs and forms; 

• Lead in interdepartmental activities with Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are always available for use; 

• Lead in the training of new and existing laboratory personnel on current and new procedures; 

• Oversee and document activities following GDP 

• Lead team meetings; 

• Provide regular updates to management  

• Effectively communicate technical information to technical and non-technical audiences; 

• 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;  

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

• Perform other laboratory duties as assigned; 

• Ability to proactively communicate consistently, clearly, and honestly;  

• Strong computing skills; 

• Strong communication skills with the ability to maintain open communication with internal employees, managers and customers as needed; 

• Ability to integrate and apply feedback in a professional manner; and 

• Ability to work as part of a team. 

• Perform biennial review of Standard Operating Procedures; and 

• Report all con