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.
• 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 bioanalysis in a regulated setting.
• Ability to communicate effectively with internal teams, external clients, and regulators regarding study design, data, and outcomes.

Additional Skills & Qualifications

• Experience in a Bioanalytical CRO regulated environment is highly desirable.
• Background supporting drug development studies in both animal and human settings is preferred.
• Experience with GLP and GCP as primary regulatory frameworks, with awareness of GMP practices and the differences between GLP and GMP flexibility.
• Comfort working with ICH guidance and applying it to bioanalytical study design and interpretation.
• Experience as a Bioanalytical Principal Investigator, particularly at a Lead Scientist 2 level with approximately 7-9 years of experience, is advantageous.
• Prior progression from laboratory-based roles (e.g., at least 2 years in the lab) into lead scientist responsibilities is beneficial.
• Experience in small molecule bioanalysis and targeted LC-MS/MS quantitation is considered an asset.
• Familiarity with CRO operations, including coordination across internal and external stakeholders, is helpful.
• Strong communication and stakeholder management skills, including the ability to coach and mentor team members indirectly.
• Willingness to travel occasionally (up to approximately 10%) for cross-site collaboration, client visits, or conferences.
• Eligibility to participate in performance-based merit structures and long-term incentive plans, where applicable.
• Interest in participating in employee stock purchase plans and retirement savings programs, where offered.

Work Environment

This role operates within a bioanalytical laboratory setting as part of a central Bioanalytical Services team. The broader team includes approximately 100 employees, with around 60 chemists and a mix of associate lead scientists and lead scientists. The LCMS Lead Scientist functions as an individual contributor with indirect leadership responsibilities over team members working on assigned studies. The position is structured as a hybrid role, requiring local presence with 2-3 days on-site per week on a consistent schedule, and flexibility in selecting which days as long as they remain stable. Workload is driven by sample volume rather than strictly defined projects, so the number of active studies can vary significantly; the role may involve supporting a single large client with many projects or multiple clients with fewer projects each. The environment emphasizes GLP/GCP-regulated bioanalytical work, primarily focused on LC-MS/MS methods using Sciex mass spectrometers, LIMS, and associated analysis software. The team is growing due to expanding workload and ongoing success, with opportunities for advancement and additional openings anticipated. Occasional travel, up to approximately 10%, may be required for cross-site collaboration, client meetings, or conferences. The organization offers a flexible time off policy based on performance and business needs, a defined holiday schedule, retirement savings with company matching, and an employee stock purchase plan. Dress expectations align with a professional laboratory and office hybrid environment, with appropriate attire and safety considerations when on-site in lab areas.

Job Type & Location

This is a Permanent position based out of Madison, WI.

Pay and Benefits

The pay range for this position is $85000.00 - $110000.00/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

This is a hybrid position in Madison,WI.

Application Deadline

This position is anticipated to close on Jul 10, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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