Director, QC Clinical Operations @ From November 2015 to Present (2 months) Associate Director, Analytical Technology, Cambridge. Acting Head, QC, Cambridge @ Major responsibilities: act in the capacity of technical expert for Analytical methodologies to be able to resolve quality control issues and implement timely resolution, technical support to QC including method troubleshooting and investigations of OOS (out of specification) and AR (anomalous results). Lead internal and external method transfer and method validation. Lead methods evaluation, improvement, and implementation of new technologies in QC in collaboration with Analytical Development. Support regulatory filing by authoring QC related sections. Support validation of analytical instruments in QC laboratories. Manage GMP release and stability testing for early stage clinical programs. Development laboratory Quality systems suitable to provide flexibility and support a nimble approach for phase appropriate testing and validation to support clinical pipeline. From November 2010 to October 2015 (5 years) Principal Scientist @ From November 2000 to November 2010 (10 years 1 month) Postdoc @ From 1992 to 2000 (8 years) Greater Boston Area

MS, Doctor of Philosophy (Ph.D.), Biochemistry @ Lomonosov Moscow State University (MSU) From 1981 to 1985 Elena Belitsky is skilled in: Biotechnology, Biopharmaceuticals, GMP, Life Sciences, Pharmaceutical Industry, Validation, FDA, HPLC, Protein Chemistry, SOP, Assay Development, Drug Discovery, LIMS, Quality System, Technology Transfer