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Scientist, Analytical Development

Newark, CA 94560

Posted: 02/07/2024 Employment Type: Contract Job Category: Scientific Job Number: 599048 Is job remote?: No Country: United States

Job Description

JOB SUMMARY:
We are seeking a(n) Associate Scientist, Senior Associate Scientist, or Scientist to contribute to our growing Analytical Development team. The incumbent will participate in a team responsible for all aspects of method development, optimization, qualification/validation, 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 our projects.

This is an on-site, technical laboratory-based position that involves analytical testing of biologics. Occasional remote work may be approved on a case-by-case basis. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, Formulation Development, Research and Development, QC, and other technical groups by providing analytical testing support.

ESSENTIAL DUTIES and RESPONSIBILITIES: • Execute technical analytical methodologies to support development and qualification/validation of test methods.
• Assist in writing and reviewing of analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control where needed.
• Operate, maintain, and install 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.
• Provide support for laboratory operations – inventory tracking, reagent/solution preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GxP guidelines where required.
• Occasional weekend work may be needed based on timelines.
  Skills:
QUALIFICATION REQUIREMENTS: • Working knowledge and experience performing analytical assay techniques such as absorbance (UV) assays, SDS-PAGE, ELISA, liquid chromatography ((U)HPLC), mass spectrometry (LC-MS and/or ICP-MS), CE-SDS, icIEF.
• Experience following protocols and SOPs.
• Be able to fluently communicate across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics.
• 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.
ADDITIONAL EXPERIENCE PREFERRED, NOT REQUIRED: • Previous metrology experience (basic maintenance/troubleshooting ability).
• Knowledge of compendial assays such as Moisture Content (Karl Fischer), pH, and Light Box (Appearance) is favorable but not required.

Education: • Associate Scientist: Bachelor of Science degree in biological sciences or related field with 2+ years of experience in the biotechnology or pharmaceutical industry; or Master of Science with 0 year of industry experience. **exceptional candidates/new grads will be considered without experience
• Senior Associate Scientist: Bachelor of Science degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry; or Master of Science with 3+ years of industry experience.
• Scientist: Bachelor of Science degree in biological sciences or related field with 7+ years of progressive experience in the biotechnology or pharmaceutical industry; or Master of Science with 5+ years of industry experience; or PhD with 2+ years of industry experience.



Pay Rate Range:$30-55/hr. Title and pay will be based on our assessment of education, skills, and experience relevant to our needs for the role.
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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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