Associate Director Bioanalytics | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This Associate Director role focuses on implementing and overseeing robust biomarker testing strategies for multiple clinical trials, specifically involving biologics and Antibody-Drug Conjugates (ADCs). The successful candidate will be responsible for selecting and managing external contractors, ensuring technical appropriateness and strict regulatory compliance. Day-to-day tasks include selecting appropriate analytical technologies such as LC-MS, LBA, CBA, and flow cytometry, and overseeing method transfer, development, and analytical validation performed by contract specialty laboratories. Key requirements include a minimum of five years of experience in the pharmaceutical or biotech industry, solid expertise in assay development for PK, ADA, and biomarker testing, and in-depth knowledge of global regulatory standards (GCP/GLP, FDA, EMA). This position offers the opportunity to shape and impact critical clinical trial projects within a flexible and growth-oriented environment in Germany.
Required Skills
Education
Degree in Biochemistry, Biology, Chemistry, Pharmacy, or equivalent (PhD preferred)
Experience
- Minimum of 5 years in the pharmaceutical or biotech industry
- Solid experience in assay development and analytical validation of methods for PK, ADA, and biomarker testing
- Professional experience in global contractor selection and management
Languages
Additional
- Must be able to work in Mainz or Munich, Germany.
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