Bioanalytical Lead Scientist - Level I

Lead Scientist - I BioA in Indianapolis, IN

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.

• 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 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 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.

Minimum Qualifications:

• Bachelors (BA/BS) degree in a science or related field (i.e. chemistry, biology, molecular biology, immunology, biochemistry etc.)
• 3 years or more experience in advanced laboratory scientific methods or

scientific investigation

Preferred Qualifications:

• Masters degree or PhD. in a science field (e.g. chemistry, biology, molecular biology, immunology, biochemistry etc.)
• 2 or more years of experience in a regulated laboratory setting

Additional Job Standards:

• Excellent communication and interpersonal skills are necessary as this is a highly client