Supervisor, Reagent Manufacturing

Guardant Health•Redwood City, CA

13d•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. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Position Summary: The Reagent Manufacturing Supervisor is responsible for overseeing the daily operations of their Reagent Manufacturing team and for providing general supervision of personnel. The Reagent Manufacturing Supervisor is responsible for providing management of the manufacture of reagents, assembly of kits, and scheduling of assigned reagents. The Reagent Manufacturing Supervisor follows Good Manufacturing Practices (GMP) and documents events following current Good Documentation Practices (GDP). The Reagent Manufacturing Supervisor must also act as a liaison between Supply Chain Management, Reagent Quality Control, and Warehouse teams. The Reagent Manufacturing Supervisor will also be involved with troubleshooting, 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 excellent attention to detail, 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 team environment.

Requirements

Bachelor’s degree in Biomedical Laboratory Science, Chemistry, or related scientific or engineering field required
At least 3 years of experience in supervising teams within a high complexity GMP laboratory; with an additional 3+ years of hands-on GMP manufacturing experience required
Experience with liquid handlers and reagent formulations
Able to proactively communicate consistently, clearly, and honestly
Able to integrate and apply feedback in a professional manner
Able to work as part of a team

Responsibilities

Oversee daily operations of the Reagent Manufacturing department including but not limited to scheduling, troubleshooting and resolving technical and non-technical issues
Provide day-to-day supervision of personnel; maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties
Perform administrative duties including, but not limited to, writing employee performance evaluations, writing and reviewing SOPs, protocols, manufacturing documentation, and equipment maintenance forms as assigned
Coach and mentor Reagent Manufacturing Associates including, but not limited to, providing guidance, constructive feedback and assistance with the development of skills and career goals
Participate in introduction of process improvements, new reagent configurations and validation
Participate in inspection preparation activities as needed
Document all corrective actions taken when systems deviate from the laboratory’s established performance specifications
Lead in interdepartmental activities with Clinical Operations, Quality Assurance, Quality Control, Sustain and Support, and Supply Chain Management to ensure qualified reagents are available for use at all times
Lead in the training of new and existing laboratory personnel on current and new procedures
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 other laboratory duties as assigned
Report all concerns of test quality and/or safety to the Technical Supervisor, Laboratory Director or Safety Officer