Alicia N.

Associate Director, Quality Control at Amyris

Alicia N. has over 14 years of professional experience in the field of Quality Control and Analytical Development. Alicia began their career in 2005 as a Lab Assistant at the University of California, Davis and an Analytical Development Intern at Chiron Corporation. In 2006, they joined Transcept Pharmaceuticals as an Analytical Chemist III, where they developed and validated multiple dissolution and stability indicating HPLC methods, conducted forced degradation, pH stability, solubility, and octanol partitioning studies, and executed buccal permeability studies of drug substances and formulations. In 2010, they joined Dynavax Technologies as a Research Associate III, Analytical Development, where they carried out forced degradation, stress test, freeze-thaw stability, robustness, method transfers, method optimizations, and method validations in support of Heplisav drug product RP-HPLC, SDS-PAGE, ELISA, and DC microassay test methods, and supported toxicity studies in formulation of critical reagents and testing of in-process, release, stability, and homogeneity samples following GLP guidelines. In 2014, they joined Adamas Pharmaceuticals, Inc. as a Senior Research Associate, Analytical Development, where they initiated, managed and monitored development and GMP stability programs at CRO laboratories, conducted quality control data review and data analysis of development and GMP activities including scale up, process validation and release of clinical trial materials at CRO laboratories, and authored, reviewed and performed navigational QC on CMC sections for INDs, IMPDs, NDA, and regulatory packages to support development programs for drug substance and drug product and FDA requests. Finally, in 2017, Alicia joined Amyris as an Associate Director, Quality Control, Quality Control Manager, and Quality Control Engineer III.

Alicia N. graduated from the University of California, Davis with a Bachelor of Science in Biochemistry and Molecular Biology.

Links

Previous companies

Dynavax Technologies logo

Timeline

  • Associate Director, Quality Control

    November, 2021 - present

  • Quality Control Manager

    March, 2018

  • Quality Control Engineer III

    June, 2017

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