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Senior Scientist

Newark, CA 94560

Posted: 05/20/2024 Employment Type: Contract Job Category: Scientific Job Number: 606761 Is job remote?: No Country: United States

Job Description

We are seeking a Senior Scientist to contribute to our growing Analytical Development team. The Senior Scientist will participate in a team responsible for all aspects of method development, qualification, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for projects.

This is an on-site, technical laboratory-based position that involves development, qualification, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support.


• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Operation, maintenance, and installation of sophisticated analytical instrumentation and associated computer control systems.
• Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area.
• Provide support for laboratory operations – inventory tracking, reagent preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.



• Extensive experience performing basic analytical assay techniques: absorbance assays, SDS-PAGE, chromatography, CE-SDS, ELISA, western blot, cell-based potency assay.
• Extensive experience in common characterization techniques such as AUC, LC/MS, MFI, DLS, and CD.
• Extensive experience developing/authoring protocols, methods, and SOPs.
• Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics; R, Python, or other statistical tools.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
• GxP knowledge. 


• Neuromodulator or other toxin experience
• Experience creating and maintaining cell banks
• Familiarity with metrology process and instrument (LC, MS, CE) troubleshooting. 


• Ph.D. degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry. (Candidates with M.S. with extensive experience may be considered.)


Pay Rate Range: $50-65/hr. Salary will be commensurate with experience 
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About Newark, CA

Explore exciting job opportunities in and around Newark, California! Situated in the heart of the San Francisco Bay Area, Newark offers an unbeatable blend of career advancement and quality of life. With easy access to Silicon Valley and major tech companies, as well as the cultural delights of nearby Berkeley and Oakland, this area is a magnet for innovative professionals. Enjoy the stunning views from Mission Peak Regional Preserve, indulge in diverse cuisines along the Niles Canyon Railway, catch a show at the Fremont Center for the Arts, or cheer on the San Jose Earthquakes soccer team at Avaya Stadium. Discover why Newark, CA is the perfect place to grow your career and explore new horizons!

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