Scientist, Research Scientist, Pharmaceutical Science​/ Research

Scientist
Kelly® is looking for a Scientist to work at a premier pharmaceutical industry leader in Irvine, CA. Let us help you grow at work and discover the next step in your career, all while being a vital part of your community.

• Supporting analytical method development, validation, and transfer for drug product development, including formulation, stability, and release testing.
• Validating and verifying new or existing USP methods; writing and reviewing validation/verification protocols, reports, and SOPs.
• Conducting method improvements and modifications for commercial or new products and troubleshooting instrument or analytical issues for raw materials and finished products.
• Maintaining excellent documentation for lab notebooks, logbooks, validation and verification reports, stability studies, lot release testing, and R&D protocols.
• Operating and maintaining analytical instrumentation such as HPLC, GC, ICP, UV, FTIR, dissolution testers, Malvern Particle Analyzers, and XRD.
• Analyzing organic and inorganic compounds to determine chemical and physical properties.
• Supporting method development, validation, transfer, and feasibility studies for drug products.

• Possess a Bachelor’s degree (B.S. or higher) in Chemistry, with two or more years of relevant experience in the pharmaceutical industry (small molecules) or equivalent combination of education and experience.
• Have hands-on experience developing and validating analytical methods using HPLC and/or GC for assay, impurity analysis, residual solvents, and dissolution.
• Demonstrate proficiency in documentation practices and cGMP compliance, with prior experience supporting CMC documents for ANDA filing (preferred).
• Are skilled in using Empower software and operating a range of analytical instruments.
• Communicate effectively in English (verbal and written) for clear documentation and project updates.
• Possess strong analytical and mathematical skills, including statistical analysis, method validation, and interpretation of scientific data.
• Are self-motivated, capable of working independently, and able to prioritize and implement work with minimal supervision.
• Have experience with FDA audits for cGMP compliance (desirable).