Associate Director Bioanalytics (Mainz, RP, DE, 55131)

Biopharma Careers; Mainz; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Vacation account

Digital Learning

Performance & talent development

Leadership development

Apprenticeships

LinkedIn Learning

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Zusammenfassung

BioNTech is seeking an Associate Director Bioanalytics to shape biomarker and bioanalytical strategies across clinical programs, with emphasis on biologics and ADCs.

You will drive method development/transfer, collaborate with cross-functional teams, and manage external partnerships to ensure scientific and regulatory excellence.

Qualifikationen

• Advanced degree in a relevant scientific discipline; PhD preferred.
• Minimum 5 years of industry experience in biotech/pharma.
• Proven expertise in PK, ADA, biomarker testing assays.
• Familiarity with GCP, GLP, IVD frameworks and FDA/EMA expectations.
• Ability to communicate complex science clearly.

Aufgaben

• Drive biomarker testing strategies across clinical programs and CDx initiatives.
• Serve as scientific expert for LC-MS, LBA, CBA, flow cytometry, IHC.
• Collaborate with R&D, Translational Sciences and Clinical Pharmacology.
• Support external partners and CROs with technical excellence and compliance.
• Lead method transfer to external labs and guide development/validation.
• Provide strategic oversight of external labs for feasibility and validation.

Kenntnisse

Assay development

Analytical validation

Regulatory understanding

Communication

Problem solving

Attention to detail

Ausbildung

PhD in Biochemistry/Biology/Chemistry/Pharmacy or related

Tools

LC-MS

LBA

CBA

Flow cytometry

IHC

Jobbeschreibung

Mainz, Germany; Munich, Germany | full time | Job ID: 11699

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

Your Benefits:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.

Job ID 11699 (please always specify if you have any questions)