Dr. Nuri ERGEN

Management of 10 scientist Process development from lab scale (250ml) to clinical scale (200L) Preparation of CTD/CMC documentation Establishment of PD lab Involved in performing of risk assessment, IQ,OQ,PQ for the equipments under responsibility in accordance with GMP regulations Writing, submission, report preparation of governmental projects QbD DoE HEKcells bioprocessing for VLP based Covid19 vaccine manufacturing of drug substance for Phase 1,2 Clinical Trial under GMP conditions. Technology transfer

Recombinant Hepatitis B vaccine R&D senior research scientist - Upstream process optimization and scale up study of biosimilar Hepatitis B vaccine S.cerevisiae from Sartorius 2 L glass to 30 L stainless stell - Optimization of Hepatitis B surface antigen ELISA - Preparation reports for governmental project (Tübitak 1501)

Synthesis of a Novel Vitamin-E Analogue and Investigation of its Anticancer Properties in Breast and Prostate Cancer Cells by Biochemical, Biophysical and Molecular Biological Techniques - Experience in prostate and breast cancer cell line both functional and structural studies