San Diego, California, United States
• Fast paced GMP environment, requiring adaptability and efficiency • Managed and scheduled Bioanalytical Group in order to support Manufacturing, stability, validation, and training needs • Coordinated, guided, and trained analysts of different skill backgrounds • Supported two FDA Pre-Licensing / Pre-Approval Inspections (PLI / PAI) audits • Executed method validations for HPLC and CE-SDS methods. Authored reports for various studies and validations. • Authored, redlined, and revised SOPs and test methods for process improvements • Performed thorough investigations into quality events, and drove thorough corrective actions • Performed bioanalytical assays such CE-SDS LIF, RP-HPLC, SEC, CEX, and Peptide Mapping • Hired as QC Associate in 2015. Promoted to QC Sr. Associate in 2018, Lead in 2022, Supervisor in 2025. • Company formerly known as Tanvex BioPharma USA, Inc.
• Performed Chemical and Biochemical assays on drug samples • Tested raw materials through wet chemistry testing assays • GMP environment. Adept at proper documentation and adherence to protocols and regulations • Worked night shift (8pm to 6am) for five months with minimal supervision • Executed a Method Validation for the Sievers GE 900 TOC instruments • Worked with laboratory instruments such as spectrophotometers, TOC analyzers, pH / conductivity meters, LAL (endotoxin) plate readers, and percent oxygen analyzers • Self-driven workplace. Responsible for maintaining own schedule in order to complete assays on time and to obtain new training • Employed as a contingent through Pro Unlimited
• Independently surveyed sugar concentrations of vineyards in the Modesto area • Drove several hundred miles a week in order to survey different vineyards • Assessed and prioritized field surveys based on ripeness, quality, and vineyard needs • Advised on vineyard’s condition and harvest date
• Molecular & Cellular Biology laboratory which researched genetics and gametogenesis • Utilized fluorescent microscopy in order to photograph germlines • Independently organized and managed own research schedule