About this role
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