Associate Scientist Bioanalytics

il y a 1 mois


Gent, Belgique Argenx Temps plein

For the expansion of the Bioanalytical team, argenx is looking for a (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.

**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

**Profile**:

- 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

**Offer**:

- A competitive compensation package with extensive benefits
- 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



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