Director CMC Materials for Individualized Cancer Vaccines

• Develop and implement strategies for the life cycle of raw materials and components required for production of individualized cancer vaccines, ensuring quality, regulatory compliance, supply chain robustness, and scalability to support production for clinical trials and commercial production.
• Facilitate collaboration across key functions, including Quality, Supply Chain Management, Procurement, Regulatory Affairs, Manufacturing, Quality Control, Process Development, Analytics, and Project Management.
• Oversee the entire life cycle of raw materials and components, from clinical development through to commercialization, ensuring all materials meet regulatory requirements at every stage of the product life cycle and continuous alignment with evolving regulatory and operational requirements.
• Lead cross-functional project alignment beyond the CMC domain, involving beyond others, Clinical Development, Preclinical Development, Clinical Safety, and Program Management.
• Identify and mitigate risks associated with material supply, quality, and scalability. Drive continuous improvement initiatives to optimize material sourcing, reduce costs, ensuring readiness for commercial-scale production.

This role enables the seamless transition from research to commercial manufacturing of individualized cancer therapeutics, contributing to medical breakthroughs that improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer.

• A degree in a scientific field; an advanced degree (e.g., MSc, PhD) is strongly preferred.
• At least 8–10 years of experience in the pharmaceutical or biotechnology industry, with a minimum of 5 years specializing in materials management.
• In-depth knowledge of GMP regulations and biopharmaceutical manufacturing requirements, particularly in relation to materials. Expertise in QbD (Quality by Design) approaches with a focus on material lifecycle optimization.
• Proven leadership experience in a matrix organization, including hands-on responsibility as a direct line manager—hiring, coaching, evaluating, and developing team members—along with a demonstrated ability to drive effective cross-functional collaboration across diverse stakeholder groups.
• Preferably, experience with RNA or DNA-based products.
• Outstanding communication and interpersonal skills and demonstrated ability to work independently, prioritize tasks, and thrive in a fast-paced, dynamic environment.
• Strong intercultural competence and fluency in English (written and spoken). German language skills are advantageous.

• 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

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival, with a focus on improving the health of people worldwide by addressing diseases with high medical needs like cancer and various infectious diseases.