Savannah Frank Email & Phone Number

Nyon, Vaud, Ch

Nyon, Vaud, Ch

• Supports wide array of high through-put testing for Class III combination drug medical device including HPLC assay for drug content and impurities, and dissolution testing for API and excipients• Knowledge of setting up, running, troubleshooting, and repairing HPLC instruments• Knowledge of chromatography skills using Agilent ChemStation and OpenLab• Experience executing QC test methods, generating associated data packages, and auditing data packages by others to ensure compliance and data integrity• Able to conduct and write reports to determine root causes for OOT/OOS Investigations per company and industry SOPs and Quality Requirements• Able to lead investigations, write root cause reports, risk assessments, and verify action effectiveness/tasks regarding CAPAs and non-conformance reports • Point of contact for all chemists and projects (OPS, R&D, QC) on-going in laboratory• Adaptable to changing testing priorities in the laboratory to align with company goals and deadlines• Experienced in cross-functional collaboration with Quality, R&D, Regulatory, and Operations to ensure production quantity goals and research project goals are met

Aliso Viejo, Ca, Us

• Supported a wide array of high through-put lot release testing for Class III combination drug medical device including HPLC assay of API and excipients for content and impurities, GC for residual solvents, and bench-top mechanical testing in models • Point of communication with project managers, executive management, and key stake holders regarding project testing deliverables and reporting summarized results and metrics• Experience with method transfers and validations for analytical testing on HPLC and GC as well as large scale chemical synthesis production processes in different laboratory environments, including clean rooms and biosafety cleanrooms• Writes and executes validation and stability protocols for new products and analytical samples in accordance with internal quality SOPs and ICH, FDA, USP guidelines

Aliso Viejo, Ca, Us

• Met or exceeded all monthly production quantity goals• Performed the large-scale chemical synthesis and work-up for the manufacturing of a liquid-embolic medical device• Transferred the synthesis reaction manufacturing line from R&D lab to a production clean room following good manufacturing practices• Performed lot release testing and data packages for final product release• Trained and on-boarded chemists and technicians during product transfer on synthesis and corresponding analytical methods• Worked on experiments for the chemical formulation development of the new next generation neurovascular liquid embolic