Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs across all stages of the cancer care continuum.Guardant Healthhas launched liquid biopsy-based Guardant360 & GuardantOMNI tests for advanced stage cancer patients & LUNAR assay for research use & for use in prospective clinical trials. In parallel,Guardant Healthis actively exploring the performance of the LUNAR assay in initial studies related to screening & early detection in asymptomatic individuals.
In this role, you'll be responsible to solve complex problems & implement innovative solutions. You will provide manufacturing technology & robust solutions aimed at commercializing new products & continuously improving production processes. Working cross-functionally with engineering groups across the company, as well as with Production, Quality Control & Quality Assurance, you will resolve problems encountered on the production floor, & will apply your engineering knowledge & creativity to implement adaptations & modifications to production & to quality systems.
You must be collaborative & able to effectively participate in cross functional teams working in a variety of projects. These cross functional teams will explore, develop, optimize, test, & implement robust, scalable solutions for Guardant Health's Manufacturing Operations with attention to understanding business & user requirements & improving efficiency, throughput, & quality.
The successful candidate will apply scientific methods & engineering skills to improve the scalability of Guardant Health's Manufacturing Operations.
Essential Duties & Responsibilities:
- Optimize production processes by designing fixtures, acquiring off-the-shelf tooling & equipment, & implementing new fixturing on the production line.
- Assist in non-conformance investigation & CAPA closure.
- Execute detailed root cause analyses & recommend vetted solutions.
- Support production by training manufacturing associates & quality control technicians, creating & maintaining product & process documentation, & implementing process improvements that increase yield, efficiency, and/or throughput.
- As a point person in leading process & equipment transfer from R&D into Manufacturing Operations.
- Develop, refine & release SOPs or Forms from Development team into Manufacturing via Change Control.
- Provide user requirements to project teams to ensure manufacturability of processes/methods.
- Develop, characterize, & optimize processes using statistical techniques & engineering knowledge & experience.
- Coordinate with suppliers & other external resources needed in developing & implementing process improvement plans.
- Participate in project planning & scheduling.
- Provide sustaining support, including troubleshooting, process improvement, & new equipment specifications.
- Develop KPIs & monitor progress.
- Lead 5S & continuous improvement projects.
- Collaborate with cross functional teams on label design, Safety Data Sheets & validation activities.
- Maintain manufacturing processes in validated state.
You're an engineer with a proven track record of production floor support. You're eager to participate in troubleshooting process problems & developing solutions to resolve/mitigate risks. You are willing to work for a high growth & fast paced startup. An interdisciplinary background in molecular biology, lab automation & programming is desirable. The ideal candidate will have prior, demonstrated experience developing, testing, implementing, troubleshooting & 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. He or she will also apply engineering, molecular biology, and/or biochemistry knowledge to troubleshoot manufacturing issues.
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 & 3-5 years of related experience. An MS with 2+ years of related work experience will also be considered.
- Experience in streamlining workflows & developing robust manufacturing processes.
- Hands-on experience with operating & programming liquid handling robotics platforms. Experience with Hamilton liquid handlers is a plus.
- Experience with automated development of next-generation sequencing (NGS) assays and/or standard molecular biology techniques such as nucleic acid isolation & purification, DNA quantitation, PCR, etc.
- Experience working within regulated environments (FDA, IVD, LDT, ISO, etc.) is required.
- Strong communication & collaborative skills, working with internal & external colleagues & customers from diverse scientific, engineering, operational, & regulatory disciplines.
- Experience with statistical data analysis, monitoring data quality, & troubleshooting technical problems.
Employee may be required to lift routine office supplies & use office equipment. Work might be performed in a production or desk/office environment. There may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.
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 & will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
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