Sarah Olson Email & Phone Number

Saint Paul, Mn, Us

• 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 characterization in a cGMP environment• 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 challenges; application of QbD principles and software (JMP and Excel) to interpret data• 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 project teams and 3rd party lab; thorough knowledge of DEA regulations related to CII controlled substances• 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• Advocated for department improvements and best practices through participation on cross-functional project teams and adoption of innovative practices from other Teva sites

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.