Scientist II

Scientist II

Whitesboro, NY

Responsibilities:

• 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.
• 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, i.e. study protocol, randomization lists, COA, demographic etc.
• Work with clients to ensure studies are conducted in a manner compliant with the clients stated needs as defined by contract.
• 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.
• 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.
• 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.
• 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.

Requirements

• BS degree in a science related field with a minimum 5 years (or PhD with 3+ years) of relevant work experience in the pharmaceutical or CRO business
• Experience developing/validating pharmacokinetic (PK), immunogenicity (ADA), and biomarker ELISA-type assays needed
• Experience with MSD and Gyrolab preferred

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment