Associate Director Bioanalytics | Pharmacist (m/w/d)

Unknown Employer

Mainz am Rhein, Rheinland-Pfalz, Deutschland
Published Nov 20, 2025
Full-time
No information

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

German (Basic)English (Fluent)

Additional

  • One-year fixed-term contract