Job Purpose:
The Senior Scientist II leads study-specific laboratory activities in compliance with GxP guidelines, overseeing assay development, validation, and sample analysis for pre-clinical, clinical, and batch characterization studies. This role includes scientific consultation, project management, documentation, training, and contributing to revenue targets through efficient resource planning and client-focused execution.
Main areas of responsibility:
* 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 Study Lead, Responsible Scientist (RS) or Principal Investigator (PI).
* Study specific consultation, capacity management, reagent planning, inventory, troubleshooting, and training.
* Conduct and manage sample analysis, validation 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.
* Lead studies, manage pre- and post-contract phases (change order management, reagent plans, protocols, quotes), and support revenue generation.
* Maintain ERP timesheets and unit logging, provide training, and contribute to achieving monthly revenue targets.
Qualifications and Experience:
* Master’s degree in a natural science or 5+ years’ relevant experience.
* Strong knowledge of ligand binding techniques (e.g., immunoassays) and GxP principles (GLP, GCP, GMP, GCLP).
* Accurate record-keeping, communication and documentation skills in English.
PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.
#J-18808-Ljbffr