Planning, execution, analysis and reporting of bioanalytical projects to support immunogenicity bioanalysis using LBA (ligand-binding) and cell-based assays as the responsible scientist
Serving as Principal Investigator in accordance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
Managing the development and validation of bioanalytical methods for the quantification/qualification of large-molecule therapeutics in line with international guidelines and internal procedures
Providing scientific support to technical staff during sample analysis; reviewing and discussing analytical results and ensuring adherence to project capacities
Writing, editing and reviewing bioanalytical protocols, reports and (on request) regulatory documents
Discussing new project opportunities and advising clients on optimal project designs in collaboration with colleagues from Business Development
Reviewing service cost estimates with particular consideration of clinical study designs and translating these into appropriate bioanalytical protocols
Presenting results and observations from projects to clients
Representing bioanalytical projects during client audits and regulatory inspections in cooperation with Quality Assurance (QA)

PhD / Postdoc in a scientific discipline (e.g., biotechnology, biology, biochemistry) or equivalent background
At least 2 years of hands-on experience in bioanalysis with a focus on immunogenicity (ADA, NAb)
Initial experience with GLP/GCP and relevant regulatory guidelines (FDA, EMA)
Scientific expertise in immunology and immunological methods
Excellent project management skills, analytical thinking, problem-solving abilities and strong self-organization
Very good German and English skills, both written and spoken
Very good communication skills
High personal commitment and a strong sense of urgency in a fast-changing environment
High initiative and strong team spirit

Project Manager – Immunology, Bioanalysis

Key skills