Associate Scientist
- Develop, optimize, and validate ligand binding assays (e.g., ELISA, MSD, Gyrolab) for quantifying therapeutic molecules in PK studies.
- Perform routine bioanalysis of preclinical and clinical samples under GLP and non-GLP conditions.
- Analyze and interpret experimental data, ensuring accuracy, reproducibility, and regulatory compliance.
- Troubleshoot and resolve technical issues related to assay performance and instrumentation.
- Maintain detailed and organized records of experimental procedures and results in laboratory notebooks and electronic systems.
- Contribute to the preparation of bioanalytical reports, method validation reports, and regulatory submissions.
- Collaborate with pharmacokinetics, toxicology, clinical, and regulatory teams to support drug development programs.
- Ensure compliance with regulatory guidelines (GLP, FDA, EMA) and company policies for bioanalytical studies.
- Bachelor's or master's degree in Biochemistry, Molecular Biology, Immunology, Pharmaceutical Sciences, or a related field.
- Entry-level candidates, including recent graduates, are encouraged to apply. Hands-on experience in ligand binding assay development, validation, and sample analysis through coursework, internships, or research projects is a plus.
- Familiarity with bioanalytical techniques such as ELISA, MSD, and Gyrolab.
- Knowledge of pharmacokinetics, immunogenicity assessment, and bioanalytical regulatory requirements.
- Experience in a GLP-compliant environment is a plus.
- Strong analytical and problem-solving skills with the ability to troubleshoot assay performance issues.
- Excellent organizational skills and attention to detail.
- Effective communication and teamwork skills to collaborate with multidisciplinary teams.
- Experience with automated liquid handling systems for bioanalysis is a plus; training opportunities will be provided for candidates eager to learn automation.
- Proficient in coding language for data analysis and automation (e.g., Python, Kotlin).
- Familiarity with software for data analysis (e.g., SoftMax Pro, Watson LIMS, GraphPad Prism).
- Understanding of regulatory expectations for bioanalytical method validation (FDA, EMA, ICH guidelines).
- Bilingual (Mandarin/English) preferred.
- Be part of a collaborative and innovative bioanalytical team supporting groundbreaking drug development.
- Gain exposure to cutting-edge bioanalytical techniques and regulatory-driven workflows.
- Opportunity for career growth within a dynamic and fast-paced research environment.
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