Reagent Manufacturing Associate II job vacancy in Guardant Health, (Redwood City, CA 94063)

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We got a new job details in Guardant Health & they are Hiring Candidates for Reagent Manufacturing Associate II

Job Details
Company Name :
Guardant Health
Company Location :
Redwood City, CA 94063
Job Position :
Reagent Manufacturing Associate II
Job Category :
Jobs in California

Job Description :
Company Description
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. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Job Description
In this role, you’ll be responsible for developing, implementing, and scaling complex automated workflows within a regulated next-generation sequencing manufacturing area.
The Automation Process Engineer II will be directly responsible for leading or contributing to all aspects of reagent manufacturing automation development from concept, requirements definition, and manual development to adaptation, optimization, troubleshooting and validation. Will leverage an understanding of molecular biology, biochemistry and engineering principles to troubleshoot mechanical problems and improve manufacturing processes. Apply scientific methods and engineering skills to improve the scalability of Guardant Health’s manufacturing workflows.
As an Automation Process Engineer II, you must be collaborative and able to effectively participate in or lead cross functional teams working in a variety of projects. These cross functional teams will explore, develop, optimize, test, and implement robust, scalable solutions for Guardant Health’s reagent manufacturing workflows with attention to understanding business and user requirements and improving efficiency, throughput, and quality. You will also contribute to protocol generation, report writing and presentation preparation.
Essential Duties and Responsibilities:

Lead or contribute to development of new or existing reagent manufacturing processes and technologies along with innovation in current workflows.
Lead or contribute to the design, development, optimization, and implementation of automated liquid handling processes, systems, and streamlined workflows.
Collaborate closely with other development, operation, and quality & regulatory teams to enable the development and implementation of new workflows.
Analyze workflows, identify bottlenecks, and develop solutions to improve efficiency, throughput, cost, and quality.
Modify robotic liquid handling workstations and integrated robotic systems. Experience with Hamilton liquid handlers or equivalent is a plus.
Experience working within regulated environments (IVD, LDT, etc.) is a plus.

Work with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
Develop, refine and release SOPs or Manufacturing Forms from Development team into Manufacturing via Change Control.
Lead continuous improvements efforts.
Participate in Deviations, Non conformances and CAPA’s as deemed necessary.
Participate in testing, verifying, and transferring technology(new products) from development to manufacturing.

Qualifications
The ideal candidate will have prior, demonstrated experience developing, testing, implementing, troubleshooting and supporting kit assembly, liquid dispensing, formulation and/or warehouse automation using a requirements-driven approach in a clinical laboratory or other molecular biology-based laboratory setting.
You also have:

A BS degree in engineering or science, preferably in molecular biology, genetics or biochemistry, bioengineering, mechanical/chemical engineering or a closely-related discipline and 3-5 years of related experience. An MS with 2+ years of related work experience will also be considered.
Experience in streamlining workflows and developing robust manufacturing processes.
Hands-on experience with operating and programming liquid handling robotics platforms. Experience with Hamilton liquid handlers or equivalent is a plus.
Experience working within regulated environments (FDA, IVD, LDT, etc.) is a plus.
Strong communication and collaborative skills, working with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
Experience with statistical data analysis, monitoring data quality, and troubleshooting technical problems.
Experience applying engineering, molecular biology, and/or biochemistry knowledge to troubleshoot manufacturing issues.

Work Environment:
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.
Additional Information
Hybrid Work Model: At Guardant Health, we have 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.
Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.
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.
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 Peopleteam@guardanthealth.com
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.
All your information will be kept confidential according to EEO guidelines. To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.
Please visit our career page at: http://www.guardanthealth.com/jobs/
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