We have a rare opportunity for an experienced Principal Investigator/Bioanalytical Lead Scientist I
to support our LC/MS Bioanalytical Study Team
in Madison, WI.
Labcorp Drug Development'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!Essential Job Duties:
- 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.
- 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.
- 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.
- 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
Join us and discover why Labcorp Drug Development has been named by Fortune® Magazine as one of the World's Most Admired Companies 2022 for the fourth consecutive year, by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career! #LI-SD1Labcorp is proud to be an Equal Opportunity Employer:
- Masters (MS) degree in science or related field
- Experience may be substituted for education
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.
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