Description:
The Scientist, Attribute Sciences, Process Development develops, qualifies, and transfers phase-appropriate analytical methods supporting small molecule and antibody-drug conjugate (Client) 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.
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 Client process development, optimization, technology transfer, and control strategy development.
- Characterize intermediates, starting materials, drug substances, and drug products for small molecules and Client 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.
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 (Client) development including impurity characterization, stability studies, and DS/DP analytical activities.
Must Have Skills:
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.