LCMS Lead Scientist

Job Title:

LCMS Lead Scientist

Job Description

The LCMS Lead Scientist serves as the primary scientific point of contact for bioanalytical studies of moderate complexity, providing full oversight of LC-MS/MS projects from method readiness through reporting. This role focuses on data review, regulatory interactions, and study governance rather than hands-on laboratory work. The LCMS Lead Scientist ensures that methods are validated, executed, and documented in alignment with internal, client, and regulatory requirements, while acting as the responsible scientist or principal investigator for assigned studies.

Responsibilities

+ Provide overall scientific leadership and serve as the responsible scientist or principal investigator for assigned LC-MS/MS bioanalytical studies.

+ Oversee the full conduct of bioanalytical studies, ensuring methods are ready, validated, executed, and documented according to internal, client, and regulatory expectations.

+ Review and approve raw LC-MS/MS data, ensuring data integrity, scientific soundness, and compliance with GLP/GCP and applicable guidelines.

+ Sign off on study reports and act as the single point of control for studies conducted at the test site.

+ Evaluate LC-MS/MS data, identify issues, and make informed decisions on the appropriateness and validity of study results.

+ Develop, review, and approve study protocols and sample analysis plans, ensuring they align with project objectives and regulatory requirements.

+ Coordinate and direct the work of method development chemists, validation chemists, and sample analysis teams to ensure timely and accurate study execution.

+ Ensure methods and analyses are appropriately validated and ready for use in targeted LC-MS/MS quantitation of specific biomarkers or molecules.

+ Collaborate with internal stakeholders and external clients to align expectations, address technical questions, and provide scientific updates on study progress.

+ Interact with regulators and support clinical and pre-clinical (including animal and human) studies by providing scientific justification and data explanations as needed.

+ Coach and indirectly lead a team of up to 20 associates and lead scientists, providing scientific guidance, mentoring, and oversight of their work on assigned studies.

+ Ensure adherence to GLP and GCP guidelines, ICH guidance, and relevant regulatory frameworks, while understanding the differences and flexibilities relative to GMP environments.

+ Support bioanalytical drug development studies in a regulated CRO environment, particularly for small molecule programs where applicable.

+ Use LC-MS/MS instrumentation and associated analysis software, including Sciex mass spectrometers and LIMS, to support data review and interpretation.

+ Manage multiple concurrent projects and client engagements, adjusting priorities based on workload and sample volumes rather than strict project counts.

+ Participate in cross-site or client visits and scientific conferences as needed, representing the bioanalytical team and supporting relationship-building efforts.

+ Contribute to continuous improvement of bioanalytical processes, documentation practices, and data review workflows within the bioanalytical services group.

Essential Skills

+ B.S. or Master's degree in a Life Science discipline such as Chemistry, Biology, Biochemistry, or a related field.

+ 2-5 years of hands-on experience working with LC-MS or LC-MS/MS systems, with at least 2 years of direct experience operating mass spectrometers.

+ Demonstrated experience reviewing and interpreting mass spectrometry data, particularly targeted LC-MS/MS quantitation of specific biomarkers or molecules.

+ Previous experience as a Lead Scientist, Responsible Scientist, or Principal Investigator with full or primary responsibility for study oversight.

+ Proven ability to serve as the signing scientist on studies, acting as the single point of control for bioanalytical work conducted at a test site.

+ Experience in a regulated bioanalytical CRO environment, ideally supporting drug development studies.

+ At least 2 years of experience working under GLP regulations, with familiarity with GLP/GCP-focused guidance and practices.

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Experience with Sciex mass spectrometers and associated LC-MS/MS analysis software.

+ Proven track record of data review and approval, including evaluation of raw data, chromatograms, and quantitative results.

+ Experience developing and reviewing protocols and sample analysis plans, and ensuring method validation readiness.

+ Understanding of ICH guidance relevant to bioanalytical studies and how it applies in a GLP/GCP environment.

+ Strong project management capabilities, including coordination of multiple studies and stakeholders.

+ Familiarity with LIMS (Laboratory Information Management Systems) and related laboratory informatics tools.

+ Knowledge of FDA expectations and regulatory requirements for bioanalytical method validation and study conduct.

+ Experience working with small molecule…