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.
For the expansion of the Bioanalytical team, we are looking for a (Associate) Scientist Bioanalytics in EMEA & USA, 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.
You 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. You should 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.
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
You are:
- 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
- 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
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, 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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
