Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Associate/Director of Continuous Laboratory Improvement is accountable all aspects of process excellence & continuous improvement within Guardant Health's Operations department with a focus on DNA sequencing & assay development. This position is responsible for identifying & executing on continuous improvement activities, leading cross-functional process improvement initiatives, & managing vendors & team members to ensure timely & efficient execution of department & company objectives. The position is dedicated to business process reengineering (analysis, mapping & optimization) to enable the routine delivery of exceptional business process performance (better, faster, cheaper).
Essential Duties & Responsibilities:
- Develops the global continuous improvement strategy which aligns to the business strategy & operational strategy while taking into account present operational realities.
- Support a Quality first culture by initiating & supporting the improvement & continuation of initiatives driving accuracy & consistent adherence to regulations.
- Determine & implement the most effective ways to create & execute production plans for Guardant Health's products. Develop & deploy Capacity Analysis tools to increase productivity, maximize efficiency, & manage human capital more effectively.
- Workclosely with R&D to understand new product designs & transform process knowledge into high throughput production methods for production & manufacturing.
- Define product specifications, processing parameters & operational boundaries through collaboration with R&D during the development phase.
- Collaborate with Technology Development, Automation, QC, QA, IT/Software, Bioinformatics & Operations to develop, verify & validate all new processes, including reviewing/updating pFMEAs.
- Develop test plans, protocols, batch records, & reports to ensure designs & processes meet product specifications, regulatory requirements & standards.
- Oversee all aspects of tech transfer for new products including post-release QA.
- Identify, develop, recommend & implement efficiency initiatives associated with manufacturing & QC processes.
- Assist all departments in setting meaningful KPIs & measurement of actual performance against productivity standards.
- Work across multiple departments to define & maintain the process used for improvement idea intake & prioritization, standardizing tools & templates used for process mapping/data modeling, & deliverables to facilitate rapid change.
- Develop a mechanism to capture & track the benefits & savings associated with operational improvement initiatives to illustrate the sustained benefit of the improvements.
- Manage a small team by being both coach & champion of implementing operational quick wins' as well as a continuous improvement program effort across the organization, including the skills, capabilities, & mindsets to sustain the changes.
- Promotes & facilities diagnosis of the workflow impediments & other inefficiencies in Operations.
- Develop & implement controls and/or metric monitoring capabilities to identify potential issues/trends as they occur.
- Requires a BS degree in Business, Engineering, or related discipline
- 10+ years project management experience & a BA or BS or; 8+ years of relevant experience & a MS or MBA. Relevant experience consists of a cross functional role within the biotech/pharmaceutical industry with understanding of clinical workflow processes.
- 5+ years of experience in an Operational Excellence, Business Excellence or Process Engineering role.
- Strong facilitator of workshops & process improvement initiatives using continuous improvement methodologies with a track record of realized improvements.
- Ability to interact with multiple layers of the organization with success in influencing at all levels.
- Ability to develop & mentor team members & drive accountability
- Experience in developing organizational metrics & visual management systems for key performance indicators.
- Highly skilled in visualization tools, SharePoint, Microsoft Office (Word, PowerPoint, Excel, Visio, Project).
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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