Anton Ponomarenko
Director of CMC Quality Assurance
About
I am an experienced leader in Quality Control (QC) and Quality Validation in Biologics industry. I have lead teams of up to 40 people with several layers of organization.
My expertise includes equipment qualification and analytical method / process / GXP computer validation.
- I spearheaded initiatives ensuring precision and reliability in product testing through QC analytical method validation.
- I led qualification of site equipment, ensuring optimal performance.
- I am an expert in sterilization, being one of the co-authors of the PDA technical report on sterilization and Stem-in-Place monograms.
I managed a robust supply center stability program, elevating product quality and consistency.
I implemented a comprehensive QC continued method verification program, upholding stringent quality standards.
I spearheaded the program for implementation of global compendia and regulations into the site operation activities.
Contact Information
Professional Email
ant****@89bio.com
Personal Email
akc****@yahoo.com
Work Phone
(***) ***-***
Mobile
(***) ***-***
Local Location
San Francisco Bay Area, United States
Industry
Biotechnology
Designation
Director of CMC Quality Assurance
Birthday
June 13
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