Manager* 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.
Manager* GMP / CMC Drug Product
At BioNTech, you will be part of our CMC management drug product team supporting all clinical projects with respect to product quality, CMO management, and CMC documentation for regulatory dossiers.
The position is initially limited to 1 year as part of a parental leave replacement.
Your responsibilities in detail:
- Management of CMC operational activities for drug product manufacturing e.g. assessment of critical quality attributes, critical process parameters, in-process controls, process validation, drug product quality and characterization, reference standards, stability studies etc.
- Coordination of internal and external development tasks towards production of products for pharmaceutical use (e.g. liposomes, RNA nanoparticle formulations, excipients) in compliance with GMP
- Ensure the timely availability of required information and contribution to respective documents (e.g. risk analysis, change controls, IND/IMPD, BLA/MAA) in close collaboration with other technical teams and regulatory affairs
- Communication with internal manufacturing sites, supervision of CMOs and analytical laboratories for GMP manufacturing and quality control, to ensure the supply for clinical trials
What you have to offer:
- PhD in life sciences or Masters level education with significant CMC experience in a pharmaceutical environment
- Good knowledge of GMP and CMC considerations related to the manufacture of pharmaceutical products
- Working experience in CMC/GMP management or Project/Program management
- Knowledge of formulation and production processes relating to pharmaceutical development (preference for specific knowledge of colloidal systems, drug delivery, nanoparticle preparations and/or RNA or DNA-based products), ideally first experience in supporting the transfer of products from development to market
- Very good communication skills including very good German and/or English language skills and excellent organization and presentation skills
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries
- 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 RoKo50 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 7243 (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!
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