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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.
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
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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