Villy B.

About Villy B.

With an educational foundation in Biochemistry and Molecular Biology from the University of California, Davis, I am currently advancing my expertise as a Graduate Student Researcher at California State University-Sacramento and a Laboratory Analyst at Nivagen Pharmaceuticals, Inc. My core competencies lie in the development and optimization of analytical methods, critical thinking, and delivering informative presentations.At Nivagen Pharmaceuticals, our team ensures compliance with stringent regulatory standards, where I play a significant role in extractable and leachable studies. My contributions include method validation and GMP analysis for impurity and stability testing in drug products, working with techniques such as ICP-MS and HPLC. I am driven by the pursuit of excellence in drug development and am committed to contributing to a team that values integrity, collaboration, and innovation in the field of pharmaceuticals.

Experience

1. Research Chemist

   Nivagen Pharmaceuticals, Inc.

   Nov 2021 — Present · Davis, CA, US

   Conduct GMP testing of release and stability batches, including drug products (IV bags, vials, API), in compliance with FDA regulations for extractable and leachable (E&L) studies using LC-MS ICP-MS, HPLC, UPLC, UV-Vis, pH meter, and osmometer.2. Develop and validate analytical methods for raw materials and drug product impurity testing, ensuring compliance with USP 232, FDA, GLP, and cGMP regulations.3. Lead method development and validation for elemental impurity analysis using ICP-MS and related substance impurity testing via HPLC/UPLC, eliminating outsourcing costs.4. Perform routine troubleshooting, calibration, and maintenance of ICP-MS following SOP guidelines.5. Review raw and QA/QC data to ensure compliance with ICH guidelines, mitigating audit risks.6. Develop, qualify, and test analytical methods in both GMP and non-GMP settings.7. Ensure timely completion of all testing, including special project/protocol testing.8. Generate analytical data and reports for FDA submissions, including ANDA filings.9. Implement and maintain SOPs for ICP-MS and HPLC to enhance lab efficiency and consistency.10. Collaborate with cross-functional teams, including QA, Regulatory Affairs, and Product Development, to align analytical methods with project timelines and regulatory requirements.

Education

• Sacramento City College

  Biochemistry and Molecular Biology

  2016 — 2019

• University of California, Davis

  Bachelor's degree , Biochemistry and Molecular Biology

  2019 — 2021

• California State University-Sacramento

  Master of Science - MS, Chemistry