Introduction
For the expansion of the Bioanalytical team, our client is looking for a 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.
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 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.
Job description
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
1. Review of method validation plans and reports
2. Review of bioanalytical sample analysis plans and reports of non-clinical and/or clinical studies
3. Review and provide input in clinical trial related documents (protocol, reports, data transfer agreement, lab manual,..) as well as regulatory documents
4. Supports the development of bioanalytical strategies in collaboration with bioanalytical, project team and clinical teams.
5. Initiates and follows up on troubleshooting of bioanalytical methods
6. Presenting results and findings at internal multidisciplinary project/clinical teams
Profile
7. Master degree or equivalent by experience( in the field of life sciences)
8. Experience in managing Contract Research Organizations (CROs) is considered an asset
9. Good knowledge of bioanalytical techniques specifically in the field of biologics and antibodies
10. Solid knowledge in the development and validation of bioanalytical assays including the respective regulatory guidelines (GLP and GCP)
11. Hands-on experience with ligand-binding bioanalytical methods on ELISA, MSD or Gyrolab is considered an asset
12. Excellent interpersonal skills, enjoys working in multidisciplinary teams and with external parties
13. Excellent organizational and communication skills
14. Able to work independently
15. Strong emphasis on quality
16. Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company
Offer
A competitive compensation package with extensive benefits, final level and remuneration are
determined in function of experience
Exposure to all aspects of nonclinical and clinical development in the company, but also with external
vendors, contract partners and the scientific world
A work environment in a human-sized, dynamic, rapidly growing biotech company