Senior Scientist I - LCMS/MS

Role Overview

We are seeking a Senior Scientist I to lead LC-MS/MS bioanalytical laboratory studies, develop and validate bioanalytical and immunological assays, and ensure regulatory compliance, driving high-quality study delivery and scientific excellence.

Key Responsibilities

• 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.
  

Qualifications & Experience

Required:

• Master’s degree in a natural science or 4-5 years’ relevant experience.


• 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).


• 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.