Speaker Profile

Dr. Chitra Edwin

Founder, Biotechnology Consulting Solutions, Ltd.

Dr. Chitra Edwin, Ph.D., RAC. has significant product development and management experience in biotechnology and diagnostic companies. She has managed projects from concept, R&D through manufacturing transfer, and has been a key member in the development of products for AIDS and cancer that have obtained FDA approval and are commercially available. She has successfully established and managed GLP and CLIA compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals. Dr. Edwin’s responsibilities have included the pre-clinical development of therapeutic biologics, vaccines and diagnostics. She has functioned as a facilitator between academia and industry that culminated in contractual service agreements, and organized professional meetings with representatives from academia and the bioscience industry.

Dr. Edwin has held management positions at Chiron Corporation (currently Siemens Healthcare) and MassBiologics (formerly the Massachusetts Biologic Laboratories). Dr. Edwin is an Adjunct Associate Professor of Pharmaceutical Sciences, Director of the Capstone project, College of Pharmacy, University of Cincinnati where she teaches regulatory compliance and pharmaceutical product development, and mentors students in the Master’s in Drug Development program. She offered a training course in GMP as part of the Global Training Network, WHO Department of Vaccines and Biologicals, and frequently conducts webinars on product development and regulatory compliance for reputed e-learning companies.

Dr. Edwin has been a consultant for the biotechnology, and diagnostics industry since 2005, and founded Biotechnology Consulting Solutions, Ltd. in 2006 (www.biotechconsultsolns.com). Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota, followed by post-doctoral training in Infectious Diseases at the Harvard Medical School and the Dana Farber Cancer Institute. She has secured Regulatory Affairs board certification (RAC). She is a Review Board member of Opus Institutional Review Board (IRB).

She was a co-founder and President of the Graduate Women in Science (Massachusetts chapter). Memberships have been held in Sigma Xi; Scientific Research Society, ASM, AAAS, RAPS, MIT Forum, GWIS, the Foreign Policy Leadership Council of Greater Cincinnati, BioOhio and Kindervelt.

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