Vijaya G. Email & Phone Number

Bedford, Nh, Us

Bedford, Nh, Us

Toronto, Ontario, Canada

• Specialized in classification of chemicals according to Canadian customs tariff HS codes, US harmonized tariff schedules, UK/EU tariff-commodity codes• Controlled drug status assessments of over 100,000+ chemicals; established process maps and procedures to systematically assess controlled drug status of chemicals• Implemented a crucial organization-wide protocols to ensure compliance in procurement, production and sale of all controlled substances• Specialized in classification of chemicals according to following Acts/Regulations (Canadian and international): Controlled Drugs and Substances Act, Food and Drug Regulations, Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, Precursor Control Regulations, Cannabis Regulations, International Narcotics Control Board, Ozone-depleting Substances and Halocarbon Alternatives Regulations, Chemical Weapons Convention (OPCW), Biological Weapons Convention (BWC), Australia Group materials, Explosives Regulations, Export and Import Regulations, Canadian Environmental Protection Act, PCB Regulations, Prohibition of Certain Toxic Substances Regulations, Rotterdam, Stockholm Conventions• Actively manage regulatory dossiers submissions, export and import permit applications, annual reports (INCB, CWC), controlled drug license renewals and amendments with regulatory authorities• Chemistry-Subject Matter Expert within the Compliance team; provide regulatory support and response to queries pertaining to chemistry and regulations to stakeholders• Act as a key liaison between the Compliance team and other departments within the organization, facilitating production, export, import of controlled drugs, and other regulated materials, and site-wide IFS implementation• Lead internal audits-initiate, investigate, review NCRs, CAPA for internal and other departments. Compliance-Subject Matter Expert for new ERP implementations and establish Order to Cash stream process flow maps

Toronto, Ontario, Canada

• Design and independently execute organic synthesis R&D projects on wide spectrum of compounds – medicinal chemistry targets, biochemicals, impurities, reference standards, and drug analogs• Purification and isolation of target compounds using various techniques such as crystallization, solid phase/solution phase extractions, precipitation, trituration, distillation, and by chromatographic separations using ion exchange IEX resin column, cellulose/gel column and normal phase/reverse phase C18 silica chromatography via manual and Biotage/Buchi chromatographic systems• Investigate synthetic problems and devise alternative strategies to resolve hurdles; troubleshoot during process development phase; optimize conditions for scale-up processes and ensure delivery of target products within specification and timeline• Independently interpret all analytical data and spectroscopic characterization of intermediates and targets; collaborate with internal analytical team for qualitative and quantitative analysis• Accomplished 50+ R&D projects over 4 years; manage and advance multiple projects concurrently and communicate critical experimental plans, project updates to Lab Supervisor

Alberta Glycomics Centre

Glycoworld

Ph.D., Synthetic Organic Chemistry

Thesis Title: Synthesis of septanosides through an oxyglycal route and studies of their conformational and mesophase behavior My research.

M.Sc., Organic Chemistry, First Class With Distinction

Medicinal Chemistry-Organic Synthesis Thesis title: Oxidation Studies on 1-Phenylsulfonyl-2 (or 3)- Methyl- 3 (or 2)- Substituted Indoles.

Bachelor Of Science - Bs, Chemistry, University Gold Medalist And First Class With Distinction

Courses Completed: Organic Chemistry, Inorganic Chemistry, Physical Chemistry, Bio-organic Chemistry, Pharmaceutical Sciences, Medicinal.