Scientist Bioanalytics

About the role

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are looking for an Associate scientist Bioanalytics, who supports the implementation and execution of the bioanalytical strategies for the non-clinical and/or clinical development programs in tight collaboration with the project teams. The candidate will be the key representative of the bioanalytical team in one or multiple non-clinical/clinical teams and will be exposed to different phases of drug development.

Responsibilities::

• As a bioanalytical study monitor you are responsible for the method transfer and validation to bioanalytical vendors and to keep oversight on BA study phases (GLP and GCP) of non-clinical/clinical studies, in close collaboration with the project team and the bioanalytical project manager.
• Review of method validation plans and reports
• Review of bioanalytical sample analysis plans and reports of non-clinical and/or clinical studies
• Review and provide input in clinical trial related documents (protocol, reports, data transfer agreement, lab manual,..) as well as regulatory documents
• Supports the development of bioanalytical strategies in collaboration with bioanalytical, project team and clinical teams.
• Initiates and follows up on troubleshooting of bioanalytical methods.
• Presenting results and findings at internal multidisciplinary project/clinical teams

Presenting results and findings at internal multidisciplinary project/clinical teams

Qualifications :

• Master degree or equivalent by experience( in the field of life sciences.
• Experience in managing Contract Research Organizations (CROs) is considered an asset
• Good knowledge of bioanalytical techniques specifically in the field of biologics and antibodies
• Have solid knowledge of scientific and regulatory requirements of bioanalytical method development and validation for PK,PD and/or immunogenicity assays.
• Hands-on experience with ligand binding assays and strong communication,skills are considered an asset
• Solid knowledge in the development and validation of bioanalytical assays including the respective regulatory guidelines (GLP and GCP
• Hands-on experience with ligand-binding bioanalytical methods on ELISA, MSD or Gyrolab is considered an asset
• Excellent interpersonal skills, enjoys working in multidisciplinary teams and with external parties
• Excellent organizational and communication skills
• Able to work independently
• Strong emphasis on quality
• Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company