Principal Scientist – ICON plc

Job Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

What you’ll do:
• 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 is 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.

Minimum Requirements

Bachelor’s degree in chemistry, biology, biochemistry, immunology, or molecular biology, in a bioanalytical setting.

For our Immunoassay and Biomarker laboratories, we require at least three years of experience in a regulated environment using immunoassay techniques (ELISA, MSD, Luminex, Quanterix, SMCxPro, Gyros Lab, Ella).

WHO YOU ARE:

You will thrive at ICON if you enjoy a fast-paced environment, want to grow with some of the most dedicated scientists and leaders in clinical trials, and can work both individually and in a collaborative team atmosphere. No matter what part of ICON you work in, you are contributing to solving some of the most complex healthcare challenges and are helping to deliver new medicines and devices that are impacting millions of peoples’ lives, right across the world.

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.