Senior Scientist Bioanalytics

06/04/21

Location

Industriepark-Zwijnaarde 7 Zwijnaarde Belgium

Function type

Senior Scientist

Vacancy

For the expansion of the Bioanalytical team, argenx is looking for a Senior Scientist Bioanalytics, who leads the implementation of the bioanalytical strategies for the clinical development programs in tight collaboration with R&D, project team and clinical teams.

He/She will be the key representative of the bioanalytical team in one or multiple Project Teams and is considered to be an expert bioanalytical scientist with deep understanding of scientific and regulatory requirements of bioanalytical method development and validation for PK, PD and/or immunogenicity assays.

The candidate should have at least 5 years of working industry experience in the field of Bioanalytical sciences.

Responsibilities

  • Responsible for developing bioanalytical strategies in collaboration with bioanalytical team, project and clinical teams.

  • As a study monitor, responsible for vendor selection in close collaboration with the bioanalytical project manager and sourcing manager

  • Responsible for the oversight of BA study phases of clinical trials

  • Review of sample analysis plans and bioanalysis reports

  • Review and provide input in clinical trial documents (protocol, reports, DTA, lab manual,..) and regulatory documents

  • As expert bioanalytical scientist, responsible for assay validation strategy that complies with regulatory guidelines and best industry practice.

  • Responsible for assay transfer and validation to bioanalytical vendor

  • Takes initiative, follow up and troubleshooting of the methods

  • Contribute in interactions with regulatory agencies

  • Studying relevant literature, being aware of scientific and bioanalytical development and how these might apply to the argenx clinical development programs

  • Presenting results and findings at internal multidisciplinary project/clinical teams

Profile:

  • Ph.D degree or equivalent by experience

  • At least 5 years of industry experience in the field of life sciences

  • Solid back­ground in the de­vel­op­ment and validation of bioanalytical assays including the respective regulatory guidelines (GLP and GCP) and the conduction of clinical PK/PD and immunogenicity studies

  • Extensive know-how of bioanalytical techniques specifically in the field of biologicals and antibodies

  • Experience in managing Contract Research Organizations (CROs)

  • Extensive knowledge in early drug development spanning from pre-clinical to phase III

  • Ex­cel­lent organizational and com­mu­ni­ca­tion skills

  • Strong emphasis on quality

  • Excellent interpersonal skills who enjoys working in multidisciplinary teams and with external parties

  • Able to work independently

  • 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 pre-clinical 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

Interested in this vacancy? Please apply through the career page on our website (https://www.argenx.com/careers#find-your-job)

Job application