Associate Director Bioanalytics

Associate Director Bioanalytics

BioNTech

Mainz or Munich, Germany

About the role:

Are you passionate about advancing innovative therapies from discovery into the clinic? As Associate Director Bioanalytics, you will play a pivotal role in shaping biomarker and bioanalytical strategies across multiple clinical development programs, with a particular focus on biologics and antibody-drug conjugates (ADCs).

In this role, you will work at the interface of science, clinical development, and external partnerships to drive the selection, development, transfer, and validation of cutting-edge bioanalytical methods. Your contributions will support critical decision-making in drug development and diagnostics while ensuring alignment with BioNTech’s mission.

Your Contribution:

• Drive biomarker testing strategies across multiple clinical trial programs as well as diagnostic and companion diagnostic (CDx) initiatives;
• Act as a scientific expert in selecting fit-for-purpose analytical technologies such as LC-MS, ligand-binding assays (LBA), cell-based assays (CBA), flow cytometry, and immunohistochemistry (IHC);
• Collaborate closely with cross-functional teams in R&D, Translational Sciences, and Clinical Pharmacology to ensure robust and scientifically sound bioanalytical solutions;
• Support global selection and management of external partners and specialty laboratories, ensuring technical excellence and regulatory compliance—including collaborations with vendors in China;
• Lead method transfer to external laboratories or guide method development and validation activities at contract labs;
• Provide strategic oversight of external laboratories performing feasibility studies, assay development, optimization, and validation.

A Good Match:

• Advanced degree in Biochemistry, Biology, Chemistry, Pharmacy or related scientific discipline; PhD preferred;
• At least 5 years of industry experience in biotechnology or pharmaceutical sectors;
• Proven expertise in assay development and analytical validation for pharmacokinetics (PK), immunogenicity (ADA), and biomarker testing;
• Strong understanding of relevant GCP, GLP, IVD frameworks as well as FDA/EMA regulatory expectations;
• Ability to clearly communicate complex scientific concepts in an impactful way;
• Excellent analytical thinking skills combined with attention to detail and problem-solving abilities;
• Fluent English skills; proficiency in German or Chinese is an advantage.