Covance Lead Scientist II (LC-MS/MS) in Indianapolis, Indiana
The Lead Scientist performs activities related to technical leadership for routine studies in compliance with appropriate protocol, Standard Operating Procedures (SOPs) and regulatory agency guidelines, in a timely, efficient, and quality manner. This includes supporting analytical direction, the technical conduct of analysis, and the review, documentation, and reporting of results. The Lead Scientist serves as the Study Director, Responsible Scientist, Contributing Scientist, or Principal Investigator as appropriate to support scientific work for non-regulated and regulated studies. The Lead Scientist provides internal and external customers with a central scientific contact for projects within the Bioanalytical department.
Duties and Responsibilities :
Serves as the scientific point of contact for the client.
Proactively works with the client to determine project requirements.
Leads preinitiation meetings when needed.
Communicates and monitors scientific expectations with scientific staff and clients.
Gives scientific directives to the study team.
Identifies scientific issues or scope change within the study.
Provides technical and scientific guidance to clients and other departments.
Participates in client visits as a scientific lead.
Ensures client programs meet Covance, client, and regulatory requirements.
Serves as a Study Director, Responsible Scientist, Contributing Scientist, or Principal Investigator as appropriate.
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.
Able to plan, prioritize, and manage workload for large and complex projects.
Manages scientific investigations.
Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met.
Reviews reports for scientific accuracy and completeness; signs reports final.
Approves QA project specific inspections.
Approves data archival.
Provides technical support as needed.
Leads efforts to troubleshoot and solve assay problems.
Responds to unscheduled deadlines, client needs, and crises without neglecting other responsibilities.
Participates in new employee training.
Identifies process improvement opportunities.
Performs other related duties as assigned.
Masters (MS) degree in science or related field required.
PhD in science or related field preferred.
Experience may be substituted for education.
Ability to utilize word processing software, database, spreadsheet, and specialized software.
Experience and skill with Watson, Nautilus, and Analyst a plus.
Knowledge of regulatory agency guidelines.
Skilled in the related chemistry field and with data interpretation.
Minimum of 4-5 years of related experience.
Excellent communication and interpersonal skills.
Excellent attention to detail.
Proven ability to prioritize and manage time.
Job Number 2019-26888
Job Category Scientific Advanced
Position Type Full-Time
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