Senior LC-MS/MS Bioanalysis Lead

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, 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

• 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.