- Created and implemented new phase appropriate cGMP systems including policy, procedures, work instructions to support qualification and commissioning of a brand new GMP facility consisted of 17 production suites designed to offer processing of early phase clinical products in an accelerated CDMO setting.
- Instrumental in the development and launch of antiseptic nasal solution NanoBio Protect® during COVID-19 pandemic.
- Played a key role in manufacturing of GMP material in house by creating, implementing and executing Quality management systems to guide all processes starting from the sourcing of raw materials to release of final products.
- Improved operations of QA departments significantly to support bio-manufacturing, release, and shipping of licensed products worth a million dollars.
- Managed QA and QC of multiple drug products, created an environment of open communication among line workers, production engineers and Quality Assurance department.
PhD, CQE/CQA