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Location

Darmstadt | Germany

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Job description

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director CMC Management RNA IVAC

At BioNTech, you will be part of our CMC Project Management team, supporting clinical projects from early to late development stages.

Aufgaben:

• Coordination of CMC operational activities for drug substance manufacturing across different units, e.g. process and analytical method development, assessment of critical quality attributes and critical process parameters, manufacturing
• Ensure the timely availability of information and contribution to required documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports, etc.) in close collaboration with Technical and Regulatory Affairs teams
• Act as point of contact for CMOs and analytical laboratories for GMP manufacturing and quality control, to ensure the supply of drug substance for pre-clinical and clinical studies
• Ensure achieving the program’s CMC goals by planning and monitoring budget, time and quality, and execute mitigation plans if applicable

Qualifikationsprofil:

• Degree in Chemistry, Biotechnology, Biology, or an analogous field, ideally with a PhD
• Experience in late stage biopharmaceutical drug development and tech transfer
• Demonstrated, sound understanding of RNA technology and RNA production processes
• Several years of working experience in CMC and/or GMP environment
• Experience in project management
• Very good communication skills including very good German and/or English language skills as well as excellent organization and presentation skills
• Supportive interpersonal team player, talented at collaborating cross-functionally

Benefits:

Fitness Courses

• Flexible Working Time
• Mobile Office
• Work from EU Countries (up to 20 days per year)
• Company Pension Scheme
• Childcare
• Jobticket
• Company Bike
• Leave Account

... and much more.

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Job tags

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Salary