Lead Scientist I BioA (LCMS)

Labcorp • Indianapolis, IN

7d

About The Position

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.
Labcorp’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
Position Summary:
In this role, you will lead and direct scientific work to support external methods and projects, serving as a Lead Scientist for non-regulated, GLP/GCP regulated studies while ensuring client programs meet Labcorp, client, and regulatory requirements in order to meet defined milestones along the drug development pathway.

Requirements

• A minimum of a BS degree in a life science
• 4 plus years of experience in the job discipline
• Highly effective skills in research conduct, data interpretation, and report writing
• Experience and proficiency with laboratory analytical instrumentation
• The ability to successfully perform scientific presentations
• 4-5 years of experience in the job discipline, preferred LCMS experience.
• 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
• Knowledge of regulatory agency guidelines

Nice To Haves

• Masters (MS) or PhD degree in science or related field preferred
• Experience may be substituted for education
• Experience and skill with Watson, Nautilus, and Analyst preferred

Responsibilities

• Ability to lead and direct scientific work to support internal methods and projects, of moderate complexity.
• 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.
• 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.
• Serves as a SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies as applicable.
• Evaluates data and tables to ensure regulatory guidelines and expectations are met.
• Reviews, edits and approves reports for scientific accuracy and completeness.
• Provides technical support/technical input as needed.
• May guide efforts to troubleshoot and solve assay problems.
• Recognizes the functions of different teams within Labcorp and seeks guidance when appropriate.
• Participates in scientific investigations.
• Approves QA project specific inspections.
• Approves data archival.
• Serves as the scientific point of contact for the client.
• Works with the client to determine project requirements.
• Gives scientific directives to the study team.
• Identifies scientific issues or scope changes within the study.
• Communicates and monitors scientific expectations with scientific staff.
• Proactively identifies ways to increase client satisfaction.
• Promotes quality within the study team.
• Provides a technical resource for less experienced team members.
• Actively promotes collaboration within and across groups.
• Provides appropriate coaching and recognition to team members.
• Promotes a positive impression of Labcorp internally and within the industry.
• 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.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level