Job Description

Mainz, Germany | full time | Job ID: 10586



We are seeking a strategic and visionary leader to oversee product development within a Quality Management System (QMS) framework, driving innovation and ensuring adherence to regulatory standards and ultimately launching commercial products.



As Senior Director Protein Modality Lead, you will provide leadership for all protein-based products (antibodies and antibody drug-conjugates), ensuring phase-appropriate development and compliance with key regulations such as ICH Q8, Q9, and Q10. You will build and lead a data-driven governance model, oversee critical product changes and deviations, and anticipate strategic and tactical challenges to ensure successful product development and commercialization. Additionally, you will lead a team of professionals, fostering collaboration and driving excellence in quality and compliance.

Your Responsibilities

:


Build and Lead a Data-Driven Team: Develop, implement, and lead a data- and metric-driven leadership approach under a target operating model for protein-based products. Ensure alignment with risk management principles and regulatory guidelines, including ICH Q8, Q9, Q10 and others Ensure Phase-Appropriate Development: Provide leadership for all protein-based products from a Quality Assurance perspective, ensuring phase-appropriate development while maintaining adherence to QMS and GMP standards Lead Key Product Changes: Oversee and guide critical product changes related to regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches. Ensure alignment with global standards and successful execution of changes across the product lifecycle Manage Critical Product Deviations Lead and manage critical product deviations with potential impacts on regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches. Ensure thorough investigation, resolution, and communication of deviations to mitigate risks and maintain compliance Lead and Develop the Team: Provide strong leadership to a team of Quality Assurance professionals, fostering a culture of collaboration, accountability, and excellence. Focus on team development, ensuring alignment with organizational priorities and compliance standards while empowering team members to drive their respective areas of responsibility

What you have to offer:

A degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field. Advanced degrees (e.g., MSc, PhD, MBA) are highly desirable Extensive experience in R&D Quality or Product Quality, with a proven track record of leading through product challenges related to compliance and quality and product launches Deep understanding of ICH guidelines (Q8, Q9, Q10) and their application in protein product development and lifecycle management Long-term business and pharmaceutical understanding with the ability to anticipate and navigate strategic and tactical challenges in product development and commercialization Proven ability to lead and develop teams, fostering a culture of collaboration and accountability while driving operational excellence Exceptional analytical and problem-solving skills, with the ability to manage critical product deviations and regulatory challenges effective Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels, including external partners

Your Benefits:

It's our priority to support you:


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

Apply now - We look forward to your application!

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).





Job ID 10586 (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, encourage creativity, 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