MAIN AREAS OF RESPONSIBILITY

• Lead study specific laboratory staff and ensure compliance with GxP and latest guidelines.
• Write and review SOPs and support method documentation.
• 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.
• 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.
• Stay updated on bioanalysis trends, continuous GxP-related training, implement EMA/FDA guidelines, assess systems for improvements, and share knowledge regularly.
• Ensure compliance with regulatory guidelines by maintaining SOPs, policies, and study documentation, and providing staff training and support.

As a Senior Scientist I, you will lead laboratory studies, develop and validate cutting-edge bioanalytical and immunological assays, and ensure compliance with GxP and global regulatory standards. You’ll oversee study execution, guide teams, contribute to high-quality reporting, and collaborate with clients—playing a key role in advancing impactful scientific projects.