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Job Details


Novartis

Associate Scientist, Flow Cytometry

Pharmaceuticals

All

No

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.

JOB PURPOSE & IMPACT
Execute technical and laboratory aspects of contract and/or in-house assay development projects. Design and execute laboratory experiments and testing programs, evaluate test data, and prepare associated documentation and reports. Ensure adherence to company policy on patient and client confidentiality.

ESSENTIAL DUTIES AND RESPONSIBILITIES
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• May design, create, execute and troubleshoot new procedures and assays.
• Author and review technical documents including but not limited to assay work instructions.
• Plan and execute laboratory experiments and testing of patient specimens under supervision.
• Procure and qualify required materials to perform experiments or testing.
• Perform instrument maintenance and function tests with proper documentation of all activities.
• May work directly with external vendors to resolve reagent or equipment issues.
• Perform quality control testing and ensure its acceptability.
• May identify and troubleshoot problems that may adversely affect test performance/results.
• Analyze data for trends, making recommendations to more senior scientific staff.
• Use LIMS to create batch testing worklists, enter and QC data

OTHER RESPONSIBILITIES
• 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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