Senior Director Protein Modality Lead
BioNTech SE – 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, ensuring 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, ensuring alignment with global standards and successful execution 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, ensuring 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, focusing 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 such as MSc, PhD, MBA 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 effectively.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels, including external partners.
Your Benefits
* Flexibility: flexible hours and vacation account.
* Growth: digital learning, performance & talent development, leadership development, apprenticeships, and LinkedIn Learning.
* Value: voice at the table, culture on an equal footing, opportunities to shape & impact, support for your full potential.
* Health and lifestyle: company bike.
* Mobility: job ticket and Deutschlandticket.
* Life phases: employer‑funded pension and childcare.
Apply now – we look forward to your application!
Apply to our Mainz, Germany location by sending your documents via our online form. For any questions, contact our talent acquisition team at +49 (0) 6131‑9084‑1291 (Monday‑Friday from 1 PM to 3 PM CET).
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,” and you will be informed accordingly by your BioNTech recruiter.
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