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

Labcorp•Madison, WI

1d•$80,000 - $95,000•Onsite

About The Position

Bioanalytical Lead Scientist I / Principal Investigator to support our LC/MS Bioanalytical Study Team in Madison, WI. This role leads and directs scientific work to support external methods and projects, serving as a Study Director (SD), Responsible Scientist (RS), Client Scientist (CS), Laboratory Scientist (LS), or Principal Investigator (PI) for non-regulated, GLP-regulated, and GCP-regulated studies as applicable. The position ensures client programs meet Labcorp, client, and regulatory requirements to meet defined milestones in the drug development pathway. Responsibilities include developing and reviewing protocols and sample analysis plans, reviewing data with the Method Development Team, approving validation and sample analysis methods, and independently reviewing and approving raw data. The role also ensures that any circumstances affecting study quality and integrity are identified, documented, and addressed with corrective action. The scientist will evaluate data and tables for regulatory compliance, review and approve reports for scientific accuracy and completeness, and ensure on-time delivery of high-quality data. Technical support, troubleshooting, and managing scientific investigations are key aspects, along with evaluating new proposals for technical feasibility and supporting scientific publications. The role serves as the scientific point of contact for clients, managing project requirements, leading preinitiation meetings, and giving scientific directives to the study team. Communication of scientific expectations, proactive identification of ways to increase client satisfaction, and participation in client visits as a scientific lead are also crucial. The position requires responding to unscheduled deadlines and client needs, assisting clients with experimental design, and developing compelling communication. Promoting quality, collaboration, and a positive impression of Labcorp internally and within the industry are expected. The role involves leading new employee training, identifying process improvement opportunities, advocating for Labcorp ethics and values, and fostering a high-performance culture. Additional responsibilities include participating in projects beyond lead scientist duties, providing support to other lead scientists or project managers, mentoring employees, and managing workload for large and complex projects, including high-volume study work for key clients. Accountability and responsibility regarding scientific study conduct, good knowledge of client requirements, and effective time management are essential. Performs other related duties as assigned.

Requirements

Bachelors Degree (Chemistry, Biology)
3-4 years or more experience supporting lead scientific projects that support external methods and projects
2 years or more Good Laboratory Practice (GLP) experience required
2 years or more Liquid Chromatography Mass Spectrometry experience required
2 years or more Bioanalytical Method Development and Validation
Excellent communication and interpersonal skills
Proven ability to prioritize and manage time
Excellent attention to detail
Able to utilize word processing, database, spreadsheet, and specialized software

Nice To Haves

Masters (MS) degree in science or related field preferred
1 year or more experience Watson, Nautilus, and Analyst software
1 year or more experience Root Cause Analysis
2 years or more experience working with regulatory agency guidelines and SOP's

Responsibilities

Leads and directs scientific work to support external methods and projects.
Serves as an SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies as applicable.
Ensures client programs meet Labcorp, client, and regulatory requirements in order to meet defined milestones along the drug development pathway.
Develops and reviews protocols and sample analysis plans.
Reviews data with the Method Development Team to ensure methods are ready for validation.
Approves validation methods and reviews sample analysis methods.
Independently reviews and approves raw data.
Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur and appropriate corrective action is taken.
Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met.
Reviews and approves reports for scientific accuracy and completeness.
Ensures on-time delivery of high quality data and reports.
Provides technical support as needed.
Leads efforts to troubleshoot and solve assay problems.
Recognizes the functions of different teams within Labcorp and seeks guidance when appropriate.
Manages scientific investigations.
Approves QA project specific inspections.
Approves data archival.
Evaluates new proposals for technical feasibility.
Supports scientific papers or posters which are published or presented at scientific meetings.
Serves as the scientific point of contact for the client.
Effectively works with the client to determine project requirements.
Leads preinitiation meetings when needed.
Gives scientific directives to the study team.
Identifies scientific issues or scope changes within the study.
Communicates and monitors scientific expectations with scientific staff and clients.
Proactively identifies ways to increase client satisfaction.
Participates in client visits as a scientific lead.
Responds to unscheduled deadlines, client needs, and crises without neglecting other responsibilities.
Assists clients with experimental design outside the scope of SOPs.
Develops and delivers compelling messages that connect with the audience.
Promotes quality within the study team.
Provides a technical resource for less experienced team members.
Actively promotes collaboration within and across groups.
Communicates successes and provides positive recognition to team members.
Promotes a positive impression of Labcorp internally and within the industry.
Provides technical and scientific guidance to clients and other departments.
Leads new employee training and develops training materials and schedules.
Identifies process improvement opportunities, participates in execution of initiatives.
Advocates Labcorp ethics, vision, and values; fosters a high-performance culture.
Participates in projects and tasks in addition to lead scientist responsibilities.
Regularly provides support to other lead scientists or project managers.
Mentors other employees.
Able to plan, prioritize, and manage workload for large and complex projects.
Demonstrated ability to manage high volume study work for key clients.
Takes accountability and demonstrates responsibility regarding scientific study conduct.
Good knowledge of client requirements.
Manages time effectively.
Performs other related duties as assigned.