An Ngo, PMP

Senior Manager, Chemistry, Manufacturing, and Controls (CMC) at iTolerance

An Ngo, PMP has gained extensive experience in the pharmaceutical and biotechnology industry. Starting in 2013, An worked as a Chemistry Intern at Edwards Lifesciences, where they analyzed organic and inorganic compounds for quality control. They also handled inventory and safety-related tasks.

In 2017, An joined Immunalysis as a Quality Control Chemist, where they validated immunoassays and compiled regulatory documentation. They also provided technical support to ensure customer satisfaction.

An then worked at Beckman Coulter as a Development Scientist I, characterizing and verifying features of diagnostic systems. They performed method comparison and stability studies to ensure the reliability of the systems.

Moving to City of Hope in 2019, An served as a Research Associate II, focusing on antibody production and the development of protocols for Bio-Rad and GE HPLC systems.

Later in 2019, An joined HBT LABS INC as a Pharmaceutical Research Scientist. They conducted method development and validation studies in accordance with regulatory guidelines. They also prepared technical documentation to support ongoing projects.

In 2020, An joined BioDuro-Sundia as a Scientist I and later became a Senior Manager. They contributed to the establishment and centralization of stability programs and performed method development and GMP verification/validation.

Most recently, in 2021, An joined Abzena as a Scientist II. They played a key role in establishing the non-GMP stability program, authoring protocols and reviewing analytical data.

Throughout their career, An has demonstrated expertise in analytical method development, stability studies, and regulatory compliance.

An Ngo, PMP has a strong educational background in the field of biotechnology and project management. In 2013, they started their undergraduate studies at the University of California, Berkeley, where they pursued a Bachelor's degree in Chemical Biology. An successfully completed their degree in 2016.

To further enhance their knowledge and skills in the field, An Ngo pursued higher education by enrolling in The Johns Hopkins University. From 2020 to 2022, they worked towards earning a Master of Science (MS) degree with a concentration in Regulatory Affairs, focusing on the biotechnology sector.

In addition to their formal education, An Ngo has also obtained professional certifications to strengthen their project management expertise. An is a Project Management Professional (PMP) certified by the Project Management Institute, which they achieved in December 2022. Furthermore, they hold the Certified Associate in Project Management (CAPM) certification from the same institution. However, the specific details regarding the month and year of obtaining the CAPM certification are not provided.

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Timeline

  • Senior Manager, Chemistry, Manufacturing, and Controls (CMC)

    January, 2023 - present