Description
Discover, design, and develop small-molecule and biologic therapeutics by studying their chemistry, mechanisms, and effects in living systems. Lead preclinical research to optimize safety, efficacy, formulation, and delivery, and translate findings into development candidates through analytical method development, process scale-up, and regulatory documentation under GLP/GMP and related quality standards.
- • Design and optimize small-molecule or biologic drug candidates.
- • Develop and validate in vitro and in vivo assays for potency and mechanism of action.
- • Conduct ADME and pharmacokinetic studies and model PK/PD relationships.
- • Plan and interpret preclinical efficacy and toxicology studies.
- • Formulate drug products to enhance stability and bioavailability.
- • Develop and validate analytical methods (e.g., LC-MS, HPLC, ELISA).
- • Scale up synthesis or expression and purification of lead candidates.
- • Transfer processes to manufacturing and support tech transfer.
- • Author CMC documentation and contribute to IND/CTA submissions.
- • Ensure GLP/GMP compliance and maintain accurate lab records and SOPs.
- • Manage laboratory teams and oversee experiment quality and timelines.
- • Collaborate with chemistry, biology, clinical, regulatory, and quality teams.
- • Prepare technical reports, summaries, and recommendations from study results.
- • Present findings at internal reviews, scientific conferences, and in publications.
- • Apply structure-based design and biophysical methods to target-ligand interactions.
- • Identify and validate biomarkers for pharmacodynamics and patient stratification.
- • Integrate omics and genetic data, including pharmacogenomics, into development plans.
- • Conduct stability studies and establish shelf life and storage conditions.
- • Profile impurities and elucidate degradation pathways.
- • Design and assess combination therapies and drug-drug interactions.
- • Select, qualify, and manage CROs and external partners; review protocols and data.
- • Develop statistical analysis plans and apply quantitative modeling to decisions.
- • Document inventions and support patent filings to protect intellectual property.
- • Write grant proposals or contribute to funding applications and project budgets.
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
