LCMS Lead Scientist

LCMS Lead Scientist 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. Full study‑level responsibility in a bioanalytical contract research environment, including signing as the responsible scientist on studies. Experience in the bioanalytical CRO regulated space, with a strong understanding of GLP and/or GCP as central guidance. Targeted LC‑MS/MS experience focused on quantitative analysis of specific biomarkers or molecules. Experience with small molecule bioanalysis using LC-MS/MS. Strong competency in data review and approval processes, including verification of raw data and final reports. Demonstrated ability to develop or contribute to study protocols and sample analysis plans. Experience ensuring method validation readiness and overseeing method validation activities. Familiarity with regulatory guidance and expectations for bioanalytical method validation and sample analysis, including ICH or 28 BMV guidance and FDA internal standard practices. Project management skills sufficient to oversee multiple concurrent studies and coordinate cross‑functional teams. Ability to communicate effectively with regulators, clients, and internal stakeholders regarding clinical and pre‑clinical bioanalytical studies. Comfort operating in a global bioanalytical services environment with cross‑site collaboration. For Lead Scientist 1: approximately 1–5 years of experience, typically including at least 2 years in the laboratory before moving into a lead role. For Lead Scientist 2: prior experience serving as a Bioanalytical Principal Investigator with approximately 7–9 years of total experience. Additional Skills & Qualifications Experience using Sciex mass spectrometry platforms or comparable LC-MS/MS systems; Sciex experience is preferred but other brands are considered. Familiarity with laboratory information management systems (LIMS). Experience with analysis software such as Analyst or similar LC-MS/MS data processing tools. Exposure to Nautilus or similar laboratory data management tools. Working knowledge of GLP and GCP regulatory frameworks and how they apply to bioanalytical studies. Awareness of FDA expectations and internal standard practices for bioanalytical method validation and sample analysis. Experience in a central laboratory bioanalytical environment is advantageous. Ability to indirectly coach and mentor scientific staff, providing guidance on study execution, data review, and documentation. Comfort managing a variable workload that may include multiple clients and projects, with differing project sizes and sample volumes. Awareness of GMP is acceptable, provided GLP/GCP experience and focus remain central. Interest in professional growth within a successful and expanding bioanalytical department, with opportunities for advancement (e.g., progression from Lead Scientist 1 to Lead Scientist 2). Work Environment The LCMS Lead Scientist works in a hybrid setting within a bioanalytical laboratory organization. The role is primarily office‑based and focused on data review, study oversight, and coordination rather than routine hands‑on bench work, but is closely integrated with a laboratory environment. The broader bioanalytical team includes around 100 employees, with approximately 60 chemists and a mix of associate lead scientists and lead scientists. The immediate team is growing from 16 to 18 lead and associate lead scientists in a central lab location. The position requires being local, with an expectation of working onsite 2–3 days per week on a consistent weekly schedule, while performing other responsibilities remotely as appropriate. Workload is driven by sample volumes rather than fixed project structures; the Lead Scientist may oversee multiple clients and projects at once, ranging from a single project per client to many projects for a large client. The environment emphasizes collaboration across method development, validation, sample analysis, and reporting functions, with all staff working together to ensure high‑quality bioanalytical data. Occasional travel (up to approximately 10%) may be required for cross‑site collaboration, client visits, or conferences, though such travel is typically infrequent and short in duration. The organization operates under GLP/GCP guidance with a strong focus on regulatory compliance, data integrity, and scientific excellence. The culture supports growth and expansion, with ongoing hiring driven by increasing workloads and departmental success. Job Type & Location Permanent position based out of Madison, WI. Pay and Benefits The pay range for this position is $85,000.00 - $110,000.00/yr. Medical Plan: No Charge Laboratory Testing Benefit and physical therapy Dental Plan Vision Plan Flexible Spending Accounts (FSAs) Health Care FSA Dependent Care FSA Disability Plan Short Term Disability (STD) Long Term Disability (LTD) Life and Accidental Death and Dismemberment (AD&D) Insurance Plans Basic Life Optional Life Dependent Life Optional AD&D Employee Stock Purchase Plan (ESPP) Workplace Type Hybrid position in Madison, WI. Equal Opportunity Employment The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Reasonable Accommodation If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. #J-18808-Ljbffr Actalent