Scientist, Attribute Sciences, Process Development

About the Role

The Scientist, Attribute Sciences, Process Development develops, qualifies, and transfers phase-appropriate analytical methods supporting small molecule and antibody-drug conjugate (ADC) 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.

Qualifications

Education:

• 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.

Required Technical Experience

• Hands-on experience with HPLC/UHPLC, LC-MS/MS, GC, KF, UV-Vis, FTIR, and related analytical techniques.
• Strong knowledge of method development, qualification, validation, and transfer.
• Experience supporting small molecule and antibody-drug conjugate (ADC) development including impurity characterization, stability studies, and DS/DP analytical activities.

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 small molecule and ADC process development, optimization, technology transfer, and control strategy development.
• Characterize intermediates, starting materials, drug substances, and drug products for small molecules and ADC programs.
• 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.

Pay

Target PR Range: $29–39/hour DOE