Principal Scientist

*Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
* As a member of staff, the employee I expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Travel (approximately 1%) domestic and/or international.
* *Perform Bioanalytical method development and method validation for the quantification of NCE, NBE and Biomarkers in tissues and biological fluids.
* * Work with clients to bring externally established assays and technologies in-house and/or transfer in-house assays externally as required.
* Prepare Bioanalytical method documents.
* *May manage analytical studies and act as scientific consultant to clients, and internal scientific consultant within Icon.
* *Work with laboratory management to ensure that appropriate resources are available to complete the study to timeline. May obtain all client specific documents required for the analysis, ie study protocol, randomization lists, COA, demographic etc
* *Prepare analysis plans suitable to the clients needs and obtain client approval of these.
* *Supervise analytical teams to ensure that study plans and validation plans, as appropriate are complied with.
* *Work with clients to ensure studies are conducted in a manner compliant with the clients stated needs as defined by contract, and that the project delivery, reporting specifics, timelines agreed to are met. Inform DM and QC/QA of deadlines.
* *Where appropriate, prepare invoice requests at agreed milestones ensuring that both ICON finance and the client has all necessary information to allow the invoice to be approved for payment.
* *Maintain records of work conducted in a timely and consistent manner, sufficient to allow real-time tracking of the deliverables, including tracking of revenue and resources associated with assigned studies. Inform stakeholder of changes to scope or timelines.
* Identify changes to scope of work and notify contracts of need for change order.
* *Review all data in accordance with direction documents and ensure results are documented accurately, completely and compliant with GLP/GCP regulations and SOPs .
* *Assist Project Leaders and lab staff in proactively identifying possible/potential implications of unusual results. Assist as required in an investigation and report findings.
* *Perform assay for the routine batch analysis of NCE, NBE and Biomarkers in tissues and biological fluids involving simple and complex analytical techniques. Perform laboratory work to GLP/GCP standard.
* *Document all work and results accurately, completely and compliant with GXP regulations and SOP's.
* *Generate high quality analytical results. Ensure smooth transfer of data to PI's and participate in evaluation and interpretation of data.
* *Lead investigations of instrumental and procedural problems.
* *Evaluate new equipment or technologies and make recommendations to management on utility for the laboratory and business.
* Approve release of method development and non-GXP data
* *Prepare reports (or oversee as appropriate) of the work conducted, address all QA findings and provide QA draft report in line with the terms and conditions stated in the signed contract.
* Ensure that all documentation is appropriately archived on completion of the study.
* *Check and verify laboratory notebooks and other analytical data as required.
* *Author SOPs as needed. Maintain awareness of and adherence to all current SOPs.
* *Work in compliance with GXP.
* All other duties as needed.