With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.

Your assignments

• Oversee, coordinate and guide activities performed at bioanalytical laboratories regarding PK/PD and immunogenicity method development, validation and sample analysis, before and during the execution of clinical studies
• Collaborate with clinical operations and clinical CRO to ensure adequate PK/PD and immunogenicity sample collection, management, handling and shipment
• Work with project management to align timelines and budget within the overall development plan
• Responsible for Bioanalytics e2e procurement process, and for managing contracts with bioanalytical laboratories
• Contribute to inspection readiness by filing bioanalytical documents in the eTMF and prepare for inspections
• On bioanalytical and clinical pharmacology and immunology topics, contribute to regulatory submissions, briefing books and consultations with health authorities
  
  

Your profile

Education:

• Advanced scientific degree (MsC, MD or equivalent)
  
  

Job Specific Competencies & Skills:

Languages:

• Fluency in English essential, both oral and written, other languages are an asset
  
  

Work experience:

• Minimum 2-4 years’ experience in R&D in biopharma/biotech industry
• Experience in providing scientific oversight for bioanalytical projects placed at CROs
• Experience in bioanalytical sciences in e.g. preclinical / clinical studies related to PK, immunogenicity or biomarker assays, diagnostic lab or central lab
• Good knowledge of scientific best practices, GCP, GLP and knowledge in regulatory guidelines
• Has preferably worked in a global organization in a field supporting or performing drug development
  
  

Personal Competencies & Skills:

• Good analytical and trouble shooting skills
• Action/results driven
• Good communication skills, both oral and written
• Good interpersonal, networking and relationship skills required