Scientist

Position Summary

100% Onsite - HQ-Thousand Oaks (USTO)

The Scientist, Attribute Sciences, Process Development develops, qualifies, and transfers phase-appropriate analytical methods supporting small molecule drug substance and drug product development from early clinical through commercial stages. The role collaborates closely with Process Development DS/DP teams to ensure methods are scientifically sound and compliant with regulatory requirements.

Education

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline with 1–3 years of industry experience;
• M.S. with 4–6 years of relevant pharmaceutical industry experience;
• B.S. with 6–8 years of relevant pharmaceutical industry experience.

Required Technical Experience

• Hands‑on experience with HPLC/UHPLC, GC, LC‑MS, dissolution, KF, UV‑Vis, FTIR, particle size, ICP‑MS, and related analytical techniques.
• Strong knowledge of method development, qualification, validation, and transfer.
• Experience with impurity characterization, stability studies, and DS/DP development support.

Key Responsibilities

• Develop, optimize, troubleshoot, and qualify analytical methods for characterization, release, stability, and process support.
• Develop stability‑indicating methods for critical quality attributes, including assay, impurities, dissolution, water content.
• Support process development, optimization, technology transfer, and control strategy development.
• Characterize intermediates, starting materials, drug substances, and drug products.
• Build process understanding through impurity profiling and material characterization.
• Plan and execute method qualification and validation in accordance with ICH guidelines.
• Ensure methods are robust, reproducible, and fit for purpose across the product lifecycle.
• Analyze experimental data using sound scientific and statistical approaches.
• Maintain accurate documentation in ELNs and laboratory information systems.
• Author technical reports, development summaries, protocols, and presentations.

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