Associate Director Bioanalytics | Pharmacist (m/w/d)
Unknown Employer
Job Summary
This role involves strategically implementing biomarker testing strategies across multiple clinical trial projects, specifically focusing on biologics and Antibody-Drug Conjugates (ADCs). Key responsibilities include selecting appropriate analytical technologies such as LC-MS, LBA, CBA, and flow cytometry in collaboration with R&D teams. The Associate Director will manage global contractors, ensuring their technical appropriateness and compliance with regulatory requirements. A significant part of the job involves overseeing method transfer, development, and analytical validation at external contract specialty laboratories. Candidates must possess a degree (PhD preferred) in a relevant scientific field, extensive experience in the pharmaceutical or biotech sector, and in-depth knowledge of GCP/GLP and FDA/EMA regulations to ensure successful bioanalytical operations.
Required Skills
Education
Degree (PHD preferred) in biochemistry, biology, chemistry, pharmacy or equivalent
Experience
- A 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
Languages
Additional
- One-year fixed-term contract