Covance

  • Senior Lead Scientist (Small Molecule LC-MS/MS)

    Job Location(s) US-WI-Madison
    Job Number
    2018-25019
    Job Category
    Scientific Advanced
    Position Type
    Full-Time
  • Job Overview

    • 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.
    • 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 the 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.
    • Leads efforts to troubleshoot and solve assay problems.
    • Recognizes the functions of different teams within Covance 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 works 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 identifies 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.
    • Assists 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 Covance 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 Covance 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.

    Education/Qualifications

    • PhD in science or related field, experience may be substituted for education
    • 5-7 years of experience in the job discipline
    • Experience with LC-MS/MS required

    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
    • Experience and skill with Watson, Nautilus, and Analyst preferred
    • Knowledge of regulatory agency guidelines
    • Skilled in the related chemistry field and with data interpretation

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