Vijay Narasimhan Phd, Raqc Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

• Execute QC operational activities to support the QC Testing team, including external vendor management, to ensure timely release of and compliance for cell therapies. ·
• Provide QC laboratory operational support, including generating the Use Requirement Specification (URS) instrument/equipment purchase, validation including software compliance.
• Liaise with vendors to complete IQOQPQ of equipment’s, review IOQ protocols, complete summary reports and facilitate release of equipment for GMP use.
• Author, review and/or approve SOPs related to QC lab operations and provide QC input for cross-functional SOPs relating to general GMP operations. ·
• Ensure compliance, working closely with Quality Assurance (QA) to manage QC-related quality events, including Change Control, Deviations, CAPA, and MOC. ·
• Coordinate and maintain sample management within the laboratory, including support for test scheduling and test turnaround time.

Mississauga, Ontario, Canada

• Perform Cell based assays for QC testing using TR-FRET, ELISA, Luminescence and qPCR techniques.
• GMP compliant assay method feasibility, method development, and method qualification/validation for two assays.
• Authoring and reviewing QCOs, worksheets and prepared Feasibility and method development report and Validation protocol for two assays for a client project.
• GMP complaint documentation of protocols and results for QC testing of samples and preparation of release packages.
• Working experience with LIMS and TWD-DMS and performed risk assessments, generating deviation reports for quality event, Change control.
• Perform OOS and OOE investigations, 5 Why analysis and root cause analysis for cGMP practices and SOPs deviations.

Toronto, Canada Area

• The main project I was involved is the Canadian Biomarker Integration Network in Depression (CAN-BIND). This study applied a reverse translation strategy to validate clinically identified MDD biomarkers in zebrafish.
• Generate transgenic zebrafish reporter lines for mechanistic studies and drug screens.
• Developed various zebrafish transgenic lines to screen compounds against depression, Parkinson’s disease, estrogen contamination in water.
• Screened small molecules against ALS using a zebrafish model.
• Using a transgenic zebrafish screened water samples across Ontario to identify endocrine disrupting compound contamination.
• Prepared and submitted grant proposals to government and private funding agencies

Singapore

• Elucidating how the mutation in the ciliary gene Ccdc11 affects the symmetry of the internal organs using Zebrafish as a model organism
• Generation of CRISPR mutant for ccdc11 and various other Zebrafish genes
• Expression and purification of various zebrafish ciliary proteins to synthesize antibodies
• Conducted experiments, consolidated results and published in international journals
• Presented research work in various national and international conferences

Hyderabad Area, India

• Molecular biology team leader
• Generated, reviewed and validated SOPs for various molecular biology procedures
• Communicated with clients and multiple departments to design, plan and execute projects
• Involved in stable mammalian cell line generation and protein expression in Sf9 cells.
• Assay development and validation for various targets and high throughput screening of potential drug candidates

Pharmaceutical Regulatory Affairs And Quality Operations, Gpa 4.0

Ph.D., Molecular Biology/Biophysics

• Heterologous overexpression, purification and mass spectrometric analysis of the human Tachykinin NK2 receptor and expression of the.

M.Pharm, Biotechnology

B.Pharm, Pharmacy