AT
Scientist
Aequor Technologies LLC
🇺🇸 United States
On-site
2 months ago
- ICH
2 months ago
Not enough detail in this posting to match
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; 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, 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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Scientist · Aequor Technologies LLC