Director* GMP/CMC Drug Product
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.
Director* GMP/CMC Drug Product
At BioNTech, you will be part of bringing our mRNA-based individualized tumor vaccine product family to a successful registration.
Your responsibilities in detail:
- Definition and execution of the CMC development strategy for the individualized mRNA nanoparticle product family up to registration
- Coordinate and lead the internal and external generation of CMC data (e.g. comparability) related to product quality and characterization of products, as well as strategic implementation of corresponding work packages for advanced clinical phases
- Provide guidance and technical input for early to late-stage CMC development to ensure CMC content and compliance
- Manage and coordinate CMC operational activities for drug product manufacturing e.g. assessment of critical quality attributes, critical process parameters, in-process controls, process validation, raw material and drug product quality and characterization, reference standards, stability studies etc.
- Development and implementation of new CMC processes and harmonization of existing approaches within the framework of corresponding initiatives (internal projects & initiatives management)
- Self-responsible preparation of relevant guidelines and CMC SOPs
What you have to offer:
- PhD in life sciences or Masters level education with significant CMC experience in the pharmaceutical industry
- High level of technical expertise, in-depth know-how and comprehensive knowledge on nanoparticle formulations or biologics, with significant experience in the late stage CMC area (preferentially incl. MAA/BLA)
- Proven experience in drug product CMC development strategies from early to advanced clinical development phases to ensure the content for a successful registration
- Ability to coordinate, oversight and adapt complex internal or external CMC development activities in a fast-paced dynamic environment to secure milestone goals
- Assertiveness towards external parties or other program stakeholders to contribute to platform-building
- Strong communication skills incl. fluent German and/or English language skills
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6626 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
www.biontech.com