Associate Director Bioanalytics

Gudejobs; Deutschland; Remote; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Zusammenfassung

BioNTech in Mainz, Germany seeks an Associate Director Bioanalytics to drive biomarker testing strategies and bioanalytical methods across multiple clinical programs, with emphasis on biologics and ADCs. You will bridge science, clinical development, and partnerships to shape methodologies and decisions in drug development and diagnostics.

Lead external collaborations, oversee method transfers and validation, and ensure regulatory compliance while advancing PK, ADA and biomarker testing

Qualifikationen

• PhD in Biochemistry, Biology, Chemistry, Pharmacy or related field (PhD preferred).
• 5+ years of industry experience in biotech or pharma.
• Proven expertise in assay development and analytical validation for PK/ADA/biomarker testing.
• Strong knowledge of GCP, GLP, IVD frameworks and FDA/EMA expectations.
• Excellent communication of complex science to diverse stakeholders.

Aufgaben

• Drive biomarker testing strategies across clinical programs and CDx initiatives.
• Serve as scientific expert for LC-MS, LBA, CBA, flow cytometry and IHC.
• Collaborate with R&D, Translational Sciences, and Clinical Pharmacology for robust bioanalytical solutions.
• Manage external partners and labs, ensuring quality and regulatory alignment (incl. China).
• Lead method transfer to external labs or guide development at contract labs.
• Provide strategic oversight of external labs for feasibility, assay development, optimization, validation.

Kenntnisse

Assay development

Analytical validation

Bioanalytics leadership

Cross-functional collaboration

Ausbildung

PhD preferred

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

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

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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting‑edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com