LCMS Principal Scientist

Job Title

LC-MS Principal Research Scientist

The LC-MS Principal Research Scientist serves as the primary scientific expert for pre‑clinical GLP bioanalytical method development, validation, and sample analysis using triple quadrupole LC‑MS/MS systems. The role focuses on both small and large molecule analysis, including ADCs and complex large molecule LC‑MS/MS assays and sample preparation. The scientist provides direct technical leadership, collaborates closely with clients and internal teams, ensures strict adherence to GLP and regulatory guidelines, and delivers high‑quality scientific reports in a fast‑paced, collaborative environment.

• Provide technical and scientific expertise for small and large molecule analysis using LC‑MS/MS, with a primary focus on method development and validation.
• Serve as the industry expert for pre‑clinical GLP bioanalytical study method development, validation, and sample analysis utilizing triple quadrupole LC‑MS systems.
• Act as the subject matter expert for ADCs and large molecule LC‑MS/MS analytical assays and associated sample preparation workflows.
• Serve as principal investigator or contributing scientist for LC‑MS/MS studies, ensuring scientific integrity and regulatory compliance.
• Ensure all work operates in full compliance with GLP requirements, study protocols, and standard operating procedures (SOPs).
• Maintain open, direct communication with clients, including attending recurring calls and providing scientific updates as needed.
• Prepare all necessary study and laboratory documentation required to support in‑lab analysis.
• Complete and deliver high‑quality scientific reports to clients on time, clearly summarizing methods, results, and conclusions.
• Prepare biological materials, including animal blood and tissues, for analytical assays to be run on LC‑MS/MS instrumentation.
• Maintain and document chain of custody for specimens, reagents, controls, and samples in the laboratory to ensure data integrity.
• Perform analytical assays according to protocol or other guiding documents, ensuring accurate, complete, and contemporaneous documentation.
• Maintain and update facility records related to laboratory operations and analytical activities.
• Review laboratory records, procedures, and study data for completeness, accuracy, and compliance with GLP and internal standards.
• Assist with calibration, optimization, maintenance, and data collection for analytical instruments, including LC‑MS/MS systems.
• Perform routine laboratory maintenance, such as cleaning, stocking supplies, and completing equipment maintenance tasks.
• Document deviations from laboratory procedures and study protocols in a timely manner and contribute to the development and implementation of corrective actions.
• Collaborate with internal regulatory and quality departments to ensure robust quality and compliance oversight of GLP SOPs.
• Ensure compliance with GLP, FDA ICH M10 guidelines, ALCOA+ principles, USDA, and AAALAC guidelines, and identify opportunities for process and quality improvement.
• Support multiple concurrent projects by effectively prioritizing tasks and meeting established deadlines.
• Contribute to a collaborative, values‑driven culture focused on employee development, customer focus, quality and excellence, respect, and integrity.

• Bachelor’s degree in Immunology, Biology, Chemistry, or another closely related scientific discipline.
• Minimum of 5 years of relevant GLP laboratory experience.
• Ideally a minimum of 5 years of experience as a Senior Research Scientist or equivalent in a GLP environment supporting LC‑MS/MS work.
• Experience working in a Good Laboratory Practices (GLP) environment.
• Experience working in a contract research organization (CRO) environment or in a bio/pharmaceutical setting supporting method development and validation (minimum of 2 years).
• Strong hands‑on experience with LC‑MS/MS instrumentation and associated software.
• Experience with triple quadrupole LC‑MS systems for bioanalytical method development, validation, and sample analysis.
• Experience with Shimadzu LC‑MS systems.
• Experience with SCIEX LC‑MS/MS instrumentation.
• Experience using Watson…