Description
Conduct qualitative and quantitative analyses and experiments to discover, develop, formulate, and ensure the quality and regulatory compliance of pharmaceutical compounds and products.
- • Analyze drug substances and products for identity, potency, purity, and impurities using HPLC/UPLC, LC-MS, GC, NMR, UV-Vis, and dissolution testing.
- • Develop and optimize synthetic routes, formulations, and analytical methods for APIs and drug products; validate methods per ICH/FDA guidelines.
- • Compile and interpret analytical and process data to assess performance and troubleshoot OOS/OOT and equipment issues.
- • Collaborate with medicinal, analytical, and formulation scientists and process engineers to design studies and interpret results.
- • Train and advise lab staff on GMP-compliant test procedures; oversee protocol execution.
- • Conduct synthetic reactions, stress studies, and forced degradation (heat, light, pH, oxidants) to characterize stability and degradation pathways.
- • Author technical reports, method validation protocols, batch records, and CMC documentation; ensure data integrity.
- • Prepare reagents, standards, reference materials, and test solutions per USP/EP and internal methods.
- • Maintain, calibrate, and qualify analytical instruments; troubleshoot malfunctions and coordinate service.
- • Perform QC testing on raw materials, intermediates, APIs, and finished dosage forms (assay, content uniformity, dissolution, impurities).
- • Ensure compliance with GMP, GLP, EHS, and ICH guidelines; improve laboratory safety and compliance practices.
- • Manage inventory of chemicals, reference standards, columns, and consumables; track expiry and storage conditions.
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Advanced Manufacturing
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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Sources & Standards:
This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
