Experience

Tanvex Biopharma USA, Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior QC Associate II - Microbiology

  • Jul 2023 - Present

• Senior QC Associate - Microbiology

  • May 2021 - Jul 2023



Bachem

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Scientist II - Microbiology

  • Sep 2020 - May 2021

  -Appointed as the Microbiology SME among the QC group to lead and develop the Microbiology program -Primary trainer for Routine EM, Water Sampling, Growth Promotion, and testing of Purified Water, Raw Materials, Cleaning Validations, IPC's, and API's by Bioburden, Endotoxin, and Conductivity -Drive process improvements and compliance through writing and overseeing DCR's, Deviations, CAPA's, and Change Controls -Independently write and submit quarterly and annual Microbiology trend reports for EM and Water testing -Proficient with FTIR, UV-VIS, GC, LC-MS, Specific Gravity, USP ID testing, and coordinating external testing for supporting the testing and release of Raw Materials Show less



Abzena

• United States
• Biotechnology Research
• 300 - 400 Employee

• QC Associate I - Microbiology

  • Dec 2019 - Sep 2020

  -Facilitated the release of a brand new GMP facility through the execution of Performance Qualifications for water, compressed gas, and HVAC systems while also tending to the needs of the original GMP facility -Cleanroom responsibilities include Routine EM, Water & Gas Sampling, Personnel Monitoring, and EM for Master Cell Banking and media fill operations -Lab responsibilities include Enumeration, Biological Indicators, Growth Promotion, Method Suitability, Water & Product Bioburden, Endotoxin, TOC, and Conductivity -Implemented new EM equipment units for GMP use, addressing issues such as ease of sampling and data integrity -Acted as the team's point of contact for Gowning Qualification scheduling and status among 5 departments Show less



Ajinomoto Bio-Pharma Services

• United States
• Biotechnology Research
• 500 - 600 Employee

• Senior Environmental Monitoring Assistant

  • Jul 2019 - Dec 2019

  -Create and maintain weekly schedule for up to 20 analysts ensuring that weekly, monthly, and quarterly sampling requirements are met-Lead and organize group training sessions on updated processes, SOP’s, or areas of concern-Primary trainer with proven expertise in operations-based EM of formulation, filtration, and filling rooms of the entire facility (6 formulation rooms, 5 filtration rooms, 6 fill rooms) -Reviewing and approving process-specific EM data with strict turnaround times to support timely batch release-Extensive MODA work including updating sampling plans, troubleshooting issues with other analysts, and finding root causes for data inconsistencies and implementing appropriate corrections-Proactively pursue employee development through training and accomplishing their personal training timelines; directly trained, coached, and qualified 20+ analysts during tenure-Represent the EM group as an EM Subject Matter Expert in cross-departmental and client meetings-FY 2019 Q2 Cultural Champion Nominee Show less

• Environmental Monitoring Assistant

  • Feb 2018 - Jul 2019

  -Qualified QC Analyst for providing operations-based EM support for formulation, filtration, and filling operations ranging from ISO 8 to ISO 5 cleanroom environments-Reviewing and approving routine EM data used for quarterly trend reports-Routine EM of cleanrooms (TSA, SDA), gas sampling (CCA, N2, O2), and water collection (USP/PW, WFI, Clean Steam, RO/DI)-Enumeration, gram staining, and streaking EM samples-Execution of Performance Qualifications of cleanrooms, water ports, and gas ports as both a participant and a leader-Initiating and collaborating with revisions of SOP's and other GMP documents to accurately reflect current practices-Participation in over-action level excursion and deviation investigations for routine EM and aseptic processing Show less



Primordial Genetics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Temporary Research Assistant

  • Dec 2017 - Feb 2018

  -Executed a high-throughput screening assay involving up to 50,000 samples over the span of 3 months -Collaborated with Research Associates in completing their projects to improve workflow -General lab upkeep and buffer, media, and plate preparation -Executed a high-throughput screening assay involving up to 50,000 samples over the span of 3 months -Collaborated with Research Associates in completing their projects to improve workflow -General lab upkeep and buffer, media, and plate preparation



Biosettia Inc.

• Biotechnology Research

• Laboratory Assistant

  • Oct 2015 - Dec 2016

  -Performed routine molecular biology techniques using subcloning kits and Vector NTI Software for up to 200 samples per week -Contributed in troubleshooting and completing in-house projects and custom services -Independently responsible for upkeep of lab inventory and instrumentation -Performed routine molecular biology techniques using subcloning kits and Vector NTI Software for up to 200 samples per week -Contributed in troubleshooting and completing in-house projects and custom services -Independently responsible for upkeep of lab inventory and instrumentation



UC San Diego School of Medicine

• United States
• Higher Education
• 200 - 300 Employee

• Research Assistant

  • Oct 2014 - Oct 2015

  -Principal Investigator: Ju Chen -Monitoring and maintenance of caging systems of up to 80 cages of actively breeding mice -Weaning, tailing, and genotyping mouse models for 3 postdoctoral researchers -Maintain lab inventory and glassware -Principal Investigator: Ju Chen -Monitoring and maintenance of caging systems of up to 80 cages of actively breeding mice -Weaning, tailing, and genotyping mouse models for 3 postdoctoral researchers -Maintain lab inventory and glassware