Analytical Scientist

3 weeks ago

Newark, United States Integrated Resources, Inc ( IRI ) Full time

Title: Senior Scientist

Location: Newark, CA

Duration: 12Months

JOB SUMMARY:

· Company is 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.

ESSENTIAL DUTIES and RESPONSIBILITIES:

· 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.

QUALIFICATION REQUIREMENTS:

· 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.

ADDITIONAL EXPERIENCE PREFERRED, NOT REQUIRED:

· Neuromodulator or other toxin experience

· Experience creating and maintaining cell banks.

· Familiarity with metrology process and instrument (LC, MS, CE) troubleshooting.

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