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 scientific oversight from method readiness and validation through execution, data review, and final reporting. This role focuses on leading and overseeing studies rather than performing hands-on laboratory work, ensuring that all bioanalytical activities meet internal, client, and regulatory expectations under GLP or GCP guidance.

The LCMS Lead Scientist signs off on studies as the Responsible Scientist/Principal Investigator, makes critical decisions on data appropriateness, and coordinates closely with internal teams, external clients, and regulators for both clinical and pre-clinical studies.

Responsibilities

+ Lead bioanalytical LC-MS/MS studies as the Responsible Scientist/Principal Investigator, maintaining single-point accountability for all activities conducted at the test site.

+ Oversee the full lifecycle of bioanalytical studies, ensuring methods are ready, validated, executed, and documented in accordance with GLP or GCP requirements and applicable regulatory guidance.

+ Review and approve raw LC-MS/MS data, ensuring data integrity, scientific accuracy, and regulatory compliance before final reporting.

+ Sign off on study reports, assuming responsibility for the scientific content, conclusions, and regulatory readiness of each study.

+ Develop, review, and approve study protocols and sample analysis plans, ensuring they align with client expectations, regulatory standards, and internal quality requirements.

+ Provide scientific oversight for method development, validation, and sample analysis activities, ensuring methods are suitable for targeted LC-MS/MS quantitation of specific biomarkers or molecules.

+ Serve as the primary scientific point of contact for assigned studies, communicating effectively with clients, internal stakeholders, and regulatory bodies as needed.

+ Engage in discussions with regulators for clinical and pre-clinical studies, representing the scientific strategy, data, and outcomes of assigned projects.

+ Indirectly coach and guide a team of up to approximately 0-20 team members involved in method development, validation, sample analysis, data processing, and report writing.

+ Coordinate the work of method development chemists, validation chemists, and sample analysis staff to ensure timelines, quality standards, and study objectives are met.

+ Ensure appropriate communication among all study contributors, including lab staff, project management, quality assurance, and clients.

+ Monitor study progress, anticipate potential issues in LC-MS/MS workflows, and make timely decisions to address typical LCMS challenges and data review issues.

+ Ensure that bioanalytical work adheres to relevant regulatory guidance (such as ICH and 28 BMV guidance) and internal standard operating procedures.

+ Contribute to method validation readiness assessments and ensure that validation activities meet regulatory and client expectations.

+ Review and approve documentation related to method validation, sample analysis, and study reports, ensuring completeness and clarity.

+ Support continuous improvement of bioanalytical processes by identifying opportunities to enhance data quality, efficiency, and compliance.

+ Collaborate across sites and with external clients, including occasional travel for cross-site meetings, client visits, or conferences.

+ Manage a workload that may include multiple clients and projects simultaneously, adjusting priorities based on sample volumes and business needs.

Essential Skills

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

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

+ Demonstrated experience in reviewing and interpreting mass spectrometry data, particularly LC-MS/MS data.

+ Proven experience as a Bioanalytical Lead Scientist, Responsible Scientist, or Principal Investigator in a bioanalytical setting operating under GLP or GCP regulations.

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