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

Labcorp•Madison, WI

6d•$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 in applicable study roles for non-regulated, GLP-regulated, and GCP-regulated studies. It ensures client programs meet Labcorp, client, and regulatory requirements and milestones throughout drug development. The scientist serves as a scientific point of contact for clients, guides study teams, and provides scientific and technical support to clients, colleagues, and other departments. The role oversees scientific quality and study conduct, including protocol and sample analysis plan development and review, method readiness and approval, independent review and approval of raw data, report review, and timely delivery of high-quality data. It manages scientific investigations, troubleshoots assay problems, reviews project-specific QA inspections, approves data archival, and evaluates proposals for technical feasibility. The position also supports scientific publications and presentations, leads training and mentoring, and contributes to process improvement and collaboration across groups.

Requirements

Bachelor’s degree in Chemistry, Biology, or a related area specified as Chemistry or Biology.
At least 3 years of experience supporting lead scientific projects involving external methods and projects; the posting states “3-4 years or more.”
At least 2 years of Good Laboratory Practice (GLP) and 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, databases, spreadsheets, and specialized software.
Ability to plan, prioritize, and manage workload for large and complex projects.

Nice To Haves

Master’s degree in a science 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 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 affecting study quality or integrity and take appropriate corrective action.
Evaluate data and tables to ensure regulatory guidelines and expectations are met.
Review and approve reports for scientific accuracy and completeness, and ensure 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 preinitiation 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 improve 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.
Develop and deliver compelling messages appropriate to the audience.
Promote quality, collaboration, and a positive impression of Labcorp internally and within the industry.
Provide technical and scientific guidance to clients and other departments, and serve as a technical resource for less experienced team members.
Lead new employee training and develop training materials and schedules.
Identify process improvement opportunities and participate in executing initiatives.
Advocate Labcorp ethics, vision, and values and foster a high-performance culture.
Participate in projects and tasks in addition to lead scientist responsibilities; regularly support other lead scientists or project managers.
Mentor employees and provide positive recognition to team members.
Plan, prioritize, and manage workload for large and complex projects, including high-volume study work for key clients.
Take accountability for scientific study conduct, maintain knowledge of client requirements, and manage time effectively.
Perform other related duties as assigned.