Covance Principal Investigator-Lead Scientist II-(Large Molecule Bioanalysis) in Chantilly, Virginia
We have a rare opportunity for an experienced Principal Investigator/Lead Scientist II to lead our Immunochemistry Study Team in Chantilly, VA 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!
Looking for a self-motivated, energetic individual to lead a team of individual to develop assays and analyze study sample in support of customers' drug development programs. Responsible for the development of assays using immunoassay methods, including ELISA, MSD, Cell based assays and others, in support of regulated pre-clinical and clinical bioanalytical studies for drug development programs.
Job Duties and Responsibilities:
· 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.
Masters (MS) degree in science or related field
Experience may be substituted for education
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
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.