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Principal Investigator-Lead Scientist II (LC-MS)

Company: Covance
Location: Indianapolis
Posted on: June 15, 2019

Job Description:

Job Overview Looking for a Lead Scientist to join our growing Bioanlaytical team in Indianapolis, IN. Covance's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide. Join us & be a part of this life-saving work! The Role: The Principle Investigator performs activities related to technical leadership for routine studies in compliance with appropriate protocol, Standard Operating Procedures (SOPs) and regulatory agency guidelines. The successful candidate will support the analytical direction, the technical conduct of analysis, and the review, documentation, and reporting of results, in a timely, efficient, and quality manner. The Lead Scientist serves as the Responsible Scientist or Principal Investigator as appropriate to support scientific work for non-regulated and GxP regulated studies.

  • 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. Why People choose to work at Covance? At Covance, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends. Education/Qualifications
    • Masters (MS) degree in science or related field
    • Experience may be substituted for education Experience
      • 3-4 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

Keywords: Covance, Indianapolis , Principal Investigator-Lead Scientist II (LC-MS), Other , Indianapolis, Indiana

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