Manager* Global QC Modular Manufacturing EM & Microbiological Methods
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* Global QC Modular Manufacturing EM & Microbiological Methods
Your main responsibilities are:
• Support the development, implementation, standardization and continuous improvement of a global QC governance system to facilitate the flexible, effective deployment of new modular manufacturing QC labs, systems, processes and test procedures with a focus on microbiological methods (including e.g. endotoxin, bioburden, and sterility testing) and environmental monitoring (EM) procedures, e.g. for qualification and monitoring of clean utilities (e.g. WFI, clean gases) and clean rooms
• Serve as a technical subject matter expert (SME) for microbiological methods and environmental monitoring providing technical guidance for the successful setup and qualification of fully functional GMP-compliant modular manufacturing QC units or contract testing labs
• Represent QC function at country projects including coordination across departments, work streams and BNT QC/AS&T sites
• Prepare gap and risk assessments, technical document packages, analytical method transfer protocols and sampling/monitoring plans, provide knowledge transfer and support to receiving sites during tech transfers and site ramp-up
• Support the training and onboarding of QC user-teams at new modular manufacturing sites including the development and continuous improvement of training materials and programs
What you have to offer:
• Degree in biology, chemistry, pharmacy, biotechnology or comparable
• Several years of hands-on work experience in a QC environment working on microbiological methods in the pharmaceutical or biotechnological industry under GMP requirements
• Expertise in developing and/or implementing microbiological methods and environmental monitoring / clean utility qualification programs and in troubleshooting microbiological method issues.
• Practical experience in analytical method transfer, test method management at CMOs and contract test labs as well as in project management
• Sound knowledge of microbiological and CU/EM methods, equipment qualification, experienced user of electronic systems, e. g. LIMS, ERP (SAP) and/or EM data management platforms, e.g. MODA-EM
• Sound knowledge of cGMPs or equivalent regulations for microbiology
• Fluent English skills (both written and spoken), basic German skills is of advantage
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 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 5307 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
www.biontech.com