Overview
As a Senior Scientist II, you'll lead laboratory studies, drive the development and validation of bioanalytical and immunological assays, and ensure compliance with GxP and global regulatory standards. You\'ll manage projects end-to-end, mentor teams, and partner with clients while shaping innovative solutions in a dynamic scientific environment.
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 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, 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.
* 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.
Qualifications & Experience
Required:
* Strong knowledge of analytical techniques and hands-on experience with LC/MS and GxP principles (GLP, GCP, GMP, GCLP).
* Proficient with advanced instruments (e.g., Mass Spectrometry).
* Master\'s degree in a natural science or 5+ relevant experience.
* Proficient in following protocols, and using standard equipment (centrifuges, biosafety cabinets, incubators).
* Good command of written and spoken English, with strong collaboration and negotiation skills.
Desirable:
* Experience in GxP-accredited labs.
* Willingness to travel as needed.
PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.
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