Sr. Scientist - Analytical Development

Arcus Biosciences is seeking a Senior Scientist, Analytical Development to develop analytical methodologies in support of drug substance and drug product development and the manufacture of clinical trial materials for Arcus’s clinical candidates.

The individual will be responsible for the development, optimization, and troubleshooting of analytical methods for starting materials, intermediates, drug substances, and drug products. The individual will conduct analytical method development and analysis of samples in-house and will provide oversight of outsourced activities, including technology transfer, method validation, and ongoing release and stability activities. The individual will work with multiple contract research organizations (CROs) to deliver comprehensive, consistent, and compliant analytical results for reports, certificates of analysis, and regulatory filings.

 Responsibilities:

• Develop various analytical methods to support drug substance and drug product development at various clinical stages as per ICH guidelines
• Oversee analytical method development, validation, release and stability testing activities at contract analytical, drug substance and drug product facilities
• Investigate and/or review out-of-specification/out-of-trend (OOS/OOT) laboratory investigations for scientific soundness and completeness
• Review and verify experimental data, as well as provide trend analysis in support of retest and shelf-life determination/extension
• Prepare and/or review written documents, including method validation protocols and reports, stability protocols and reports, specifications, and regulatory filings
• Collaborate with cross-functional teams to plan and execute studies to support drug substance and drug product development
• Perform analytical characterization of drug substances and drug product formulations, including impurity characterization, to support candidate selection, preclinical and clinical development

Skills/Competencies:

• Proficiency with analytical techniques, including-HPLC, mass spectrometry, and dissolution, especially as they relate to pharmaceutical quality
• Deep understanding of analytical method development and use of published literature or internal/external experts to extend understanding, as needed
• Understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH guidance)
• Highly independent and self-motivated and willingness to become integrated within a team
• Strong ability to trouble-shoot technical problems
• Good organizational skills, with ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects
• Excellent oral and written communication skills

Education/Experience:

Education:

• Ph.D. or MS/BS in Organic/Analytical Chemistry, Pharmaceutical Sciences or related discipline

Experience:

• Ph.D. candidates with 3+ years / MS/BS candidates with 8+ years of relevant experience in the pharmaceutical industry
• Extensive hands-on experience with HPLC, spectroscopic techniques, and mass spectrometry, especially as they relate to pharmaceutical quality
• Experience with CMO/CRO oversight (preferred, but not required)