Director CMC Materials for Individualized Cancer Vaccines
Mainz, Germany | full time | Job ID: 9324
The position of Director CMC Materials Lead entails strategic leadership and coordination of a cross-functional materials team responsible for ensuring the lifecycle management of materials for the production of individualized cancer therapeutics. This role is crucial in developing long-term strategies and implementing innovative processes to guarantee efficient, regulatory-compliant material supply while supporting the team in execution. The ultimate goal is to enable the seamless transition from research to commercial manufacturing of individualized cancer therapeutics through proactive planning and close collaboration with diverse department. Additionally, the selected candidate will be responsible for assembling and leading a team of subject-matter experts who will oversee CMC materials for different projects in Global Technical Development.
Your main responsibilities.
- 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.
Your profile
- 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 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 12 PM to 4 PM CET).
Job ID 9324 (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.
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