Lead study specific laboratory staff and ensure compliance with GxP and latest guidelines.
Develop, validate, and apply bioanalytical and immunological assays for pre-clinical, clinical studies, and drug batch characterization as Responsible Scientist (RS), Study Director (SD) or Principal Investigator (PI).
Study specific consultation, capacity management, reagent planning, inventory, troubleshooting, and training.
Conduct and manage sample analysis, validaton and method development studies.
Draft and review project documents (e.g., lab manuals, validation plans, sample analysis reports), ensuring high-quality reporting and client communication.
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