Research Executive
Lambda Therapeutic Research
ORGANISATIONAL OVERVIEW
Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquartersin Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA),Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-endclinical research services to the global innovator, biotech, and generic pharmaceutical industries.
JOB DETAILS
Act as a MV report writer for preparation of method validation report for small molecules and LBA based PK, PD and Immunogenicity assessment as per GLP & non GLP regulatory guidelines
KEY DELIVERABLES
Prepare Method validation Reports for pk/pd/Immunogenicity Assays as per required GLP & non GLP regulatory guidelines
Coordinate with operation team and compile relevant data required for preparation of MV Report
Coordinate with Quality control and Quality Assurance team for QC & QA review of MV Report and resolve QC & QA queries.
Ensure proper formatting and finalization of MV Report
Maintain track of method validation and manage MV report preparation to meet the timelines.
Prepare/update/maintain SOPs related to MV Report preparation.
EXPERIENCE
02 or more years of MV Report writing experience in small molecules/ Biologics/ Biosimilar as per regulartory guidelines
EDUCATIONAL QUALIFICATION
MSc in Biotechnology/Biochemistry/Life Science
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