Company Description|Job Description
Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time & identifies associated treatment options. The assay is used by more than 6,000 oncologists & we partner with more than 50 biopharma companies.
Guardant Health raised over $550M from Sequoia Capital, Khosla Ventures, Lightspeed Ventures, OrbiMed & Softbank, before having a successful IPO on NASDAQ in 2018. Guardant is led by a seasoned management team of thought leaders & successful serial entrepreneurs in next generation sequencing & rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.
To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development team is seeking a highly motivated, Senior Manager of Analytical Method Development to lead successful technical delivery of IVD quality products related to liquid biopsy sequencing assays for the early detection, treatment, & monitoring of all cancer types. At Guardant, we leverage the most advanced technologies & work with leaders in many different fields to create the most impactful, meaningful, & scalable technologies for cancer management.
As the Senior Manager of the Analytical Method Development Team, you will lead the R&D team responsible for developing, implementing, validating, & transferring analytical methods, implementing stability protocols. You will work hand-in-hand with assay & automation development teams across products. In this role, you'll have the opportunity to collaborate with industry & thought leaders in assay development, bioinformatics, quality assurance, & regulatory affairs. You will lead & participate in teams supporting IVD & LDT products throughout the development life-cycle, working under design control in accordance with applicable regulatory requirements (FDA, ISO13485).
We'll look to you to optimize complex problems at the interface of molecular biology, manufacturing, laboratory automation, quality assurance, regulatory affairs & operations. You'll influence & guide your team & your colleagues in developing new analytical assays to help us better understand reagent & assay performance.
- Lead a team of scientists & research associates to deliver analytical methods & functional reagent qualification processes
- Critically assess experimental data, provide guidance on interpretation of results, & ensure data quality & integrity
- Acts as a mentor for junior staff, provide coaching & emphasize best practices
- Introduce new technology to enhance workflow & capabilities
- Provide technical leadership for the timely resolution of complex process issues
- Ensure that required documentation is created per Quality & Regulatory requirements
- Aid in smooth transfer of processes to Operations
- Provide technical guidance on the development of new reagent specifications & qualification methods
- Establish & maintain a reagent stability program
- Generate and/or review process risk assessments and/or process FMEAs & develop risk mitigation plans
- Serve as key technical liaison for reagent vendors & contract manufacturers
- Ph.D. in Molecular Biology, Biochemistry, or related scientific discipline.
- A minimum of 5 years leading & providing technical guidance to an R&D or IVD development team.
- Experience with NGS technologies & sequencing data analysis is required
- Knowledge of 21 CFR part 820 & ISO13485 is highly desired; an eagerness to learn in this space is required
- Strong technical & problem solving skills & deep knowledge of molecular biology & biochemistry are a must
- A good sense of humor is mandatory
- A strong drive to deliver high quality results & meet aggressive timelines is required
- Effective verbal & written communication skills are essential
- Ability to interface & drive change from team members of various disciplines: Development, Marketing, Supply Chain Management, Product Management, Regulatory, Quality Assurance, & Operations
- Ability to lead & take initiative in an environment of fast paced innovation
- A driven, flexible, goal-oriented leader & collaborative team member
All your information will be kept confidential according to EEO guidelines.