Scientist #26-19023

Duration: 12-month contract

• 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.

• 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.

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

• 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.

• Analytical method development
• HPLC/UPLC
• Dissolution

• Doctorate degree OR
• Master’s degree and 2 years of experience OR
• Bachelor’s degree and 4 years of experience

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