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Reagent Manufacturing Supervisor

Guardant Health

This is a Full-time position in Redwood City, CA posted April 8, 2021.

Company Descriptionn n Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients.n n Job Descriptionn n The Reagent Manufacturing Supervisor is responsible for planning and overseeing the daily operations of the Reagent Manufacturing department and for providing general supervision of personnel.

The Reagent Manufacturing Supervisor is responsible for providing management of the manufacturing of reagents, assembling of kits, and qualification 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 Clinical Operations, Reagent Quality Control, Quality Assurance and Warehouse.n n 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.n nThe 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.n n Essential Duties And Responsibilitiesn 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, creating, writing and reviewing SOPs, manufacturing forms, protocols, 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; Participate in introduction of assay improvements, new assay configurations and validation; Participate in the regulatory inspection preparation activities as needed; Perform, review and document laboratory quality control procedures, as needed; Maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties; Document, investigate and implement corrective actions when manufacturing process deviated or product performance failed from the laboratory’s established performance specifications; Lead in the troubleshooting of manufactured reagent failure; Lead in the revision and development of Reagent Manufacturing SOPs and forms; Lead 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; Develop and monitor manufacturing key performance indicators (KPIs) to address production issues and negative trends.

Implement process improvement projects to make manufacturing process more robust and reliable with Lean manufacturing tools, such as 5S, Kaizen, Root Cause Analysis/Is it or Is not, Fishbone diagram and one piece flow.

Lead in the training of new and existing laboratory personnel on current and new procedures; Lead in the introduction of manufacturing improvements or new manufacturing configurations; Lead various projects or studies to improve and stabilize manufacturing processes.

Lead in the development of the design and acceptance criteria for Reagent Manufacturing plans; Lead and document interdepartmental training on Reagent Manufacturing changes or improvements; Oversee and document activities following cGMP, when applicable; Lead in team meetings; Provide updates to upper management regarding any quality, safety and personnel issues; Participate in quality assurance activities; 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; Perform biennial review of Standard Operating Procedures; and Report all concerns of test quality and/or safety to the Technical Supervisor, Laboratory Director or Safety Officer.n n Qualificationsn Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science, Engineering, or related field preferred; 2+ years of experience in a supervisory role requiredn At least 4 years of high complexity and volume production/laboratory/biotech experience preferred; Previous GMP laboratory work experience required; Ability to proactively communicate consistently, clearly, and honestly; Strong troubleshooting, analytical and 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; and Ability to lead a production team and work as part of a team.n n Additional Informationn n Work Environmentn n Employee may be required to lift routine office supplies and use office equipment.

Majority 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 environment.

Ability to sit for extended periods of time.n nAll your information will be kept confidential according to EEO guidelines.n n

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