Global Manufacturing Process Owner/Lead* Drug Substance (MS&T)
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.
Global Manufacturing Process Owner/Lead* Drug Substance (MS&T)
You will join the team of process owners for commercial manufacturing processes of APIs and precursors (all modalities). We are an international team coming from a broad range of backgrounds, perspectives, and life experiences. As such we take care of successfully industrialized manufacturing processes throughout their commercial life cycle, by monitoring, maintaining, and improving them. During the transition of manufacturing processes from late clinical stages into commercial we ensure scalability and manufacturability.
As Global Process Owner Drug Substance within the Global MS&T Department you will be the Single Point of Contact for the processes you own, internally as well for externals. You are enabled to make data-based decisions regarding LCM, oversee internal/external KPI’s and address Health Authorities requests.
Your focus will be on one of the following manufacturing technologies: DNA Plasmids, monoclonal Antibodies, mRNA, or Viral Vectors to ensure proper industrializing and lifecycle management. Also, the opportunity is given to satisfy your curiosity on new technologies and to grow into them.
Your main responsibilities are:
- You will be the accountable manufacturing process owner for a manufacturing process or a class of processes and the representative to our internal and external interfaces e.g. manufacturing sites, CMOs, commercial, regulatory affairs.
- Gather, maintain, and develop process knowledge (scientific, technical, historical), make it accessible to other teams and share Lessons Learned.
- Responsible leading Subject Matter Expert for a manufacturing (sub) process, aligning closely with internal departments (e.g. AS&T, tech Dev., Regulatory Affairs, QA) and external partners.
- Responsible for implementation and monitoring of KPIs and effective process risk management to ensure process performance, stability and effectiveness of improvement measures, and implement process standards across products and Manufacturing Network Partners
- Responsible for process harmonization between different manufacturing sites, lead cross-site investigations and solve process issues
- Consult in process development activities, commercial scale-up, and launches incl. support of GxP documentation for regulatory submissions
What you have to offer:
- University degree in life sciences, or chemistry providing you with a solid fundament of principles, concepts, and theories in applied sciences.
- First experiences as manufacturing process owner/lead or in supporting the owner/lead.
- Proven track record (>5-7 years) in the field of commercial pharmaceutical manufacturing processes providing you with experiences in the pharmaceutical world and leading cross-functional teams.
- Team spirit comes naturally, and you enjoy working in a dynamic environment.
- Creativity and analytical skills to develop and execute flexible approaches to support our vision of establishing a strong MS&T organization.
- Profound knowledge of EU / US cGMP guidelines and regulatory standards
- Strong communication skills in English and German enables you to adapt your communication to different levels of stakeholders
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 6085 (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