Outi Närvänen
Quality Director
Pharmaceutical Sciences
FinVector Vision
Finland
Biography
Outi Närvänen works currently as Quality Director in Finvector Vision Therapies Oy. She is responsible for Quality Assurance operations and the overall management and maintenance of the cGMP compliant quality system. She has over 15 years experience in biotech pharma industry and before that nine years experience in diagnostic industry. Outi has graduated as MSc (cell biologist) in University of Jyväskylä in Finland. She worked since 1989 as scientist in diagnostic industry (Labsystems Oy, currently part of Thermo Fisher Scientific) first in R&D developing immunoassays for detection of infective viral diseases, later in manufacturing producing monoclonal antibodies against viral antigens in pilot scale bioreactor. She joined Finvector in 1998 and started with assay development. Since 2001 she has worked as QA manager/later director being responsible for QA operations and from 2013 as Quality Director. In Finvector Outi has gained experience in understanding the quality and regulatory requirements for gene-therapy and other biological products through development starting from preclinical product up to collecting CMC data package for a marketing approval.
Research Interest
Pharmaceutical Sciences
