Vijay Narasimhan PhD, RAQC

Experience

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  GVK Biosciences

  May 2010 - Feb 2012

  Associate Scientist

  • 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

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  IMCB, Singapore

  Feb 2012 - Apr 2016

  Research Fellow

  • 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

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  St. Michael's Hospital

  May 2016 - Dec 2020

  Postdoctoral Fellow

  • 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• Generated SOPs for various procedures for animal handling and maintenance• Communicated project progress with collaborators and government funding agencies Show less

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  SGS Canada Inc

  Apr 2021 - Dec 2021

  Biotech QC Analyst II

  • 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. Show less

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  BlueRock Therapeutics

  Jan 2022 - now

  • 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. • Liaise with external vendors for outsourcing testing of samples, including sample submission, shipping and receiving an archiving the results.• Coordinate and maintain material and sample management within the laboratory for consumables, reagents, and standards inventory. · • Liaise with Logistics to coordinate sample and material inventory requirements, shipment process, and other external vendor support activities. · • Assist the IT department with equipment Data Integrity Risk Assessment and Data Integrity Control Assessment.• Perform External vendor identification, qualification and management.• Liaise with Facilities to coordinate operational support activities within the QC Laboratory. • Monitoring of REES system for equipment. Show less

  • Manager, Analytical and Quality Control

    Feb 2025 - now

  • Supervisor, Quality Control Operations

    Sept 2023 - Feb 2025

  • Senior Specialist Quality Control Operations

    Jan 2022 - Oct 2023