Principal Investigator/Bioanalytical Lead Scientist I- (LC-MS)

Labcorp•Madison, WI

8d•$80,000 - $95,000•Onsite

About The Position

Labcorp is seeking a Principal Investigator / Bioanalytical Lead Scientist to join its team in Madison, Wisconsin. The role leads scientific work supporting external methods and projects, serving as an SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies as applicable. The scientist ensures client programs meet Labcorp, client, and regulatory requirements and defined drug-development milestones. The position provides scientific leadership throughout study design and execution, including protocol and sample analysis plan development, method readiness and approval, independent raw-data review, scientific investigations, report review, and timely delivery of high-quality data. It serves as the scientific client contact, provides technical and scientific guidance to clients and internal teams, and supports assay troubleshooting, experimental design, client visits, and scientific publications or presentations. The role also promotes quality, collaboration, training, mentoring, and process improvement. The scientist plans and manages workload for large and complex projects, supports other lead scientists or project managers, and takes accountability for scientific study conduct. Work schedule is Monday through Friday on the day shift.

Requirements

Bachelor’s degree in Chemistry, Biology, or a related field as specified (Chemistry or Biology).
At least 3–4 years of experience supporting lead scientific projects that support external methods and projects.
At least 2 years of Good Laboratory Practice (GLP) experience.
At least 2 years of Liquid Chromatography Mass Spectrometry experience.
At least 2 years of Bioanalytical Method Development and Validation experience.
Excellent communication and interpersonal skills.
Proven ability to prioritize and manage time.
Excellent attention to detail.
Ability to use word processing, database, spreadsheet, and specialized software.

Nice To Haves

Master’s degree in a science field such as Chemistry or Biology, or a related field.
At least 1 year of experience with Watson, Nautilus, and Analyst software.
At least 1 year of Root Cause Analysis experience.
At least 2 years of experience working with regulatory agency guidelines and SOPs.

Responsibilities

Lead and direct scientific work supporting external methods and projects.
Serve as an SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies, as applicable.
Ensure client programs meet Labcorp, client, and regulatory requirements and defined drug-development milestones.
Develop and review protocols and sample analysis plans.
Review data with the Method Development Team to ensure methods are ready for validation.
Approve validation methods and review sample analysis methods.
Independently review and approve raw data.
Identify and document circumstances that may affect study quality or integrity and ensure appropriate corrective action is taken.
Evaluate data and tables to ensure regulatory guidelines and expectations are met.
Review and approve reports for scientific accuracy and completeness, ensuring timely delivery of high-quality data and reports.
Provide technical support and lead efforts to troubleshoot and solve assay problems.
Manage scientific investigations; approve QA project-specific inspections and data archival.
Evaluate new proposals for technical feasibility.
Support scientific papers or posters published or presented at scientific meetings.
Serve as the scientific point of contact for clients; determine project requirements and lead pre-initiation meetings when needed.
Give scientific direction to study teams; identify scientific issues or scope changes and communicate and monitor scientific expectations with staff and clients.
Identify ways to increase client satisfaction and participate in client visits as a scientific lead.
Respond to unscheduled deadlines, client needs, and crises while managing other responsibilities.
Assist clients with experimental design outside the scope of SOPs.
Provide technical and scientific guidance to clients and other departments.
Promote quality, collaboration, and a positive impression of Labcorp; communicate successes and recognize team members.
Provide technical resources to less experienced team members, lead new-employee training, develop training materials and schedules, and mentor employees.
Identify process improvement opportunities and participate in improvement initiatives.
Advocate Labcorp ethics, vision, and values and foster a high-performance culture.
Participate in projects and tasks in addition to lead scientist responsibilities and regularly support other lead scientists or project managers.
Plan, prioritize, and manage workload for large and complex projects; manage high-volume study work for key clients.
Take accountability and demonstrate responsibility for scientific study conduct; maintain knowledge of client requirements and manage time effectively.
Perform other related duties as assigned.