Associate Research Scientist - Large Molecule Bioanalysis
PharmaRegulatory AffairsQuality Assuranceregulatory submissioncroinform
Job description
Position Overview: The Associate Research Scientist will support the development and validation of bioanalytical and immunogenicity methods within a regulated laboratory environment. This role requires meticulous attention to detail, strong technical expertise in large molecule bioanalysis, and the ability to work collaboratively with cross-functional teams. Key Responsibilities:   Develop, optimize, and validate bioanalytical methods for large molecule analysis using ELISA and MSD platforms under the supervision of the Study Director Execute all laboratory activities in strict adherence to Good Laboratory Practice (GLP) guidelines, standard operating procedures (SOPs), and approved protocols Perform immunogenicity assessments and immunological testing with precision and scientific rigor Maintain comprehensive documentation and data integrity throughout all bioanalytical studies Collaborate effectively with internal teams, sponsors, regulatory agencies, and external auditors to ensure compliance and quality standards Utilize laboratory information management systems (LIMS) to record, track, and manage study data and results Contribute to the preparation of study reports and regulatory submissions as required  
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