Senior Scientist II

Job Purpose

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, 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.

Qualifications & Experience

Required:

• Strong knowledge of analytical techniques and hands-on experience with LC/MS and GxP principles (GLP, GCP, GMP, GCLP).
• Master's degree in a natural science or 5+ relevant experience.
• Proficient with advanced instruments (e.g., Mass Spectrometry, MSD, Epoch, flow cytometers, PCR systems).
• Profiecient 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.