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

Work Schedule

Monday – Friday, Day Shift

Job 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.
• Ensure 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.
• Ensuring 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 work 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 identify 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.
• Assist 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 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 leading 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.

Minimum Qualifications

• Bachelor’s 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), and Liquid Chromatography Mass Spectrometry experience required
• 2 years or more Bioanalytical Method Development and Validation required

Preferred Qualifications

• Masters (MS) degree in science (Chemistry, Biology etc.) 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

Additional Job Standards

• Excellent communication and interpersonal skills
• Proven ability to prioritize and manage time
• Excellent attention to detail
• Able to utilize word processing, databases, spreadsheet, and specialized software