Scientist #26-19241
"US Tech Solutions•Thousand Oaks, CA
•Onsite
About The Position
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.
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, 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.
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience
- HPLC/MS, MS-MS
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, p
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
