Senior LC-MS-Lead Scientist (Principal Investigator)

Job Overview:

Come join the leading global Contract Research Organization (CRO). We have a great opportunity for a Senior Principal Investigator/Lead Scientist in our LCMS group in Madison, WI.

In this role, you will oversee the validation and analysis of biological samples for various compounds and components in compliance with standard operating procedures (SOPs) and regulatory agency guidelines.

  • Able to lead and direct 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 Covance, client, and regulatory requirements in order to meet defined milestones along the drug development pathway

· Proactively identifies and responds to circumstances that may affect study success

· 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 was 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.

· Assists with efforts to troubleshoot and solve assay problems.

· Recognizes the functions of different teams within Covance 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 and clients.

· 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 Covance 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.

Labcorp Drug Development is a global, world-leading Life Sciences Contract Research Organisation that provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry.

At Labcorp Drug Development, we offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. We put our trust in science and in one another. This is your chance to become part of a team that helps to bring medicine to market sooner, as Labcorp Drug Development has helped pharmaceutical and biotech companies develop one-third of all prescriptions medicines in the market today.

Education/Qualifications:

  • Masters (MS) degree in science or related field; PhD preferred
  • Experience may be substituted for education


Experience:

  • 5+ years of experience in the job discipline
  • 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
  • Experience and skill with Watson, Nautilus, and Analyst preferred
  • Knowledge of regulatory agency guidelines


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement



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