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Research Associate/Sr. Research Associate- Genotoxicology

13.00 to 14.00 Years   Hyderabad   07 Jun, 2022
Vimta Labs Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Job Profile

    Primary Responsibilities:

    • Study Director / Study Coordinator for In Vitro and In Vivo Genotoxicology studies
    • Validation of Core battery studies in Genetic Toxicology in accordance with OECD GLP norms
    • To monitor all aspects of studies and be an effective link between the testing facility and sponsor and coordinate from initiation of client discussion till termination of the project as a project manager
    • Experimental trial designing, conducting, coordinating and supervising the In Vitro and In Vivo Genotoxicology studies for various test substances using different test system/cell lines
    • Preparation, review and approval of protocols, progress reports, summary, interim reports, and detailed schedules for the In Vitro and In Vivo Genotoxicology studies. Maintenance and propagation of various established cell lines as per GLP compliance for Genetic toxicology studies
    • Maintenance and sub culturing of various bacterial tester strains for Bacterial Reverse Mutation Assay
    • Train Study Personnel in Proof of Concept (POC) animal models and GLP related documentation and report preparation
    • Plan, perform, conduct and monitor the core batteries of Genotoxicology studies
    • Coordinating with the in-vitro Toxicology team in standardization and new method validation of cytotoxicity assays
    • Communication with Management and sponsors related to the study issues.
    • Preparation of Study proposal (quotation), Study plan, Standard operating procedures and Study status to sponsor s
    • To lead a team of people, weekly and monthly teamwork report preparation and submit to the HOD and Management
    • Overall responsibility for the planning, performing, reporting and archiving of the study
    • Ensure equipment qualification of instruments used in Genotoxicology and prepare user specification for Genotoxicology instruments and equipment to be procured for the department
    • Ensure all equipment and instruments are maintained in calibrated status. Monitor and maintain the equipment s and instruments used in laboratory to avoid misuse and ensure minimum downtime for instruments by preventive maintenance Programme
    • Check the studies for the Compliance to the regulatory requirements
    • Coordinating with QA during the facility audits and study based inspections
    ,

Keyskills :
regulatory requirementsvalidationin vitroproof of conceptstandard operating proceduresin vivocell linesmusic makingmethod validationreport preparationpreventive maintenanceanimal modelshplcresearchglpdocumentationcalibrationequipment q

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