Sarah Olson Email & Phone Number

• Led efforts to acquire ISO 17025 accreditation for the analytical lab, including significant document authoring and quality management system updates
• Managed the day-to-day laboratory operations; prioritized activities, testing needs, and resources for internal and external customers
• Expanded the laboratory’s capabilities through the implementation of new test methods, equipment, and training procedures, with a focus on compliance with ISO 13485 and cGMP regulations
• Responsible for technical review of laboratory reports, validation protocols, deviations, and investigations
• Ensured compliance with 21 CFR part 11 by implementing a company-wide data integrity policy and executing the remediation and validation of the Empower (HPLC) data collection system

Brooklyn Park, MN

• Performed extensive analytical method development, validation, stability, and method transfer testing, with a particular emphasis on stability-indicating assay and degradation product methods, and impurities.
• Delivered high-quality results under tight timelines, including allocating resources efficiently, analyzing data and drawing appropriate conclusions, and utilizing creative problem solving to troubleshoot unexpected.
• Developed a battery of category 1 in vitro tests and clinical sample preparation protocols for human abuse liability testing to analyze abuse-deterrent opioid ER/IR formulations, in collaboration with cross-functional.
• Managed and developed four junior analysts and a summer intern, ensuring each was provided guidance and opportunities for professional growth and acquisition of new skills, capabilities, and knowledge
• CMC primary author and reviewer responsibilities for regulatory documents, including IND, DSUR, NDA, and briefing packages
• Authored and reviewed of a variety of internal documents, including SOPs, validation protocols, method development and stability reports, and job training guides

St. Paul, MN

• Performed routine stability testing and authored stability reports

St. Paul, MN

• Synthesized and characterized >30 imidazoquinoline TLR agonist compounds for an immunology program
• Developed and optimized synthetic routes, including reaction troubleshooting and compound purification

Princeton, NJ

• Synthesized and characterized > 100 benzoxazole and pyrrolothiazole development compounds for an Alzheimer’s project, including scale-up synthesis of lead compounds for pre-clinical animal model testing
• Optimized synthetic routes to facilitate access to a large array of analogs

Master Of Science - Ms, Organic Chemistry

Bachelor Of Arts - Ba, Chemistry And Honors Classics, Summa Cum Laude

Activities and Societies: Member of the women's tennis team, 1996-2000; Chemistry and Latin tutor; Chemistry lab teaching assistant; Phi.