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Scientist / Sr. Scientist - Flow Cytometry




Carlsbad, California, United States

Job Description

1 in 5 men and 1 in 6 women worldwide develop cancer during their lifetime, and far too many will lose their battle. At Navigate we envision a disease free world – our talented and passionate team is at the forefront of enabling drug development by using transformative science to deliver high quality, world class clinical biomarker solutions so we can one day realize that vision. Join us on our journey to turning innovative treatment ideas into reality to improve and extend patient lives across the globe. Navigate Biopharma, a fully owned subsidiary of Novartis, provides assay development, clinical trial testing, and companion diagnostics services to companies in the precision medicine field. At present, Navigate supports 100+ clinical trials from 30+ pharma, biotech, and diagnostic companies, including 8 of the top 15 oncology companies globally.

Design, create, execute, and troubleshoot new procedures and assays with high level of independence while working on multiple projects. Drives the launch of new platforms/assays and manage projects of strategic importance and of high complexity. Possess critical thinking, initiation, management of success and failure of complex projects. Serve as subject matter expert for assay development and/or technical lead for execution of clinical sample testing from concept to completion. Provide key scientific knowledge to drive success of strategic activities. Ability to forge relationships with scientists at all levels and provide guidance. May manage performance and mentoring of other associates. Be able to direct routine tasks of associates with and without authority. Serve as the key point of contact for other functional teams, departments, commercial and external partners. Works closely with managers, directors and leadership team. Will participate on cross functional teams and projects. Develop timelines and work flows to ensure successful execution of assigned projects and processes. Strategizes to identify and mitigate risks. Makes recommendations for scientific processes and drives projects to completion.

Two Levels open: Scientist / Sr. Scientist. Candidates will be hired based on experience.

Note: Other duties may be assigned.
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• 100% onsite; 50% wet lab (working in the lab) and 50% analysis
• Hands-on experience with flow cytometry based immune profiling is a must
• Responsible for writing and reviewing technical documents.
• Must have a pro-active attitude and strong desire to deliver high quality results in a fast pace manner
• Manage & execute laboratory research and testing of patient specimens
• Conduct meetings and technical briefings for senior management
• Ensure quality standards are met in clinical sample testing
• Train and assist new staff with technical and operational procedures
• Navigate and troubleshoot complex problems that may adversely affect test performance/results and direct others to resolve problems. Streamline/simplify lab workflow while ensuring compliance.
• Ability to analyze and interpret 100-120 complex data per month as business needs.

• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions
• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed

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