Scientist* Manufacturing-Linker-Payload-Chemistry

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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.
Scientist* Manufacturing-Linker-Payload-Chemistry
As Scientist* Manufacturing-Linker-Payload-Chemistry you will be part of the team of process owners for antibody drug conjugates (ADC).
You will provide scientific and technical input to all aspects of linker-payload manufacturing within ADC commercial programs as well as to all lipid manufacturing related topics within commercial mRNA programs.
Furthermore, you will be responsible for review and approval of external/internal documentation according to regulatory expectations.
In the area of linker-payload manufacturing, you will be responsible for making decisions regarding maintenance and further development of the processes, oversee internal/external manufacturers´ performance, address Health Authorities requests, drive investigations and changes impacting the manufacturing processes throughout late clinic and commercial life cycle focused on day-to-day operations.
With regards to the topic Lipids you will be the Global MS&T representative in the Commercial Lipids team and also First Point of Contact for lipid related topics within the manufacturing network (internal and external partners)
Additionally you will serve as a direct contact for CMO partners and suppliers related to the area of expertise.
Your responsibilities:

• Responsible for adapting, optimizing, and implementing manufacturing processes to ensure efficient and high-quality production according to the processes owned by the respective global MS&T
  

department

• Responsible for interfaces between internal Stakeholders (e.g. Technical Development/CMC) and Manufacturing Network Partner and manage day-to-day operations and workflows
• Create, review, and approve (external) project documentation, including investigation reports, deviations, change controls, risk analysis, and qualification/validation reports according to regulatory guidelines
• Drive continuous improvement of linker-payload manufacturing and Lipid related processes as well as data quality, through optimizing technologies, automation, and digitalization.
• Contribute to implementation and monitoring of KPIs and effective process risk management to ensure process performance, stability and effectiveness of improvement measures
  

What you have to offer:

• Master’s degree or preferably PhD in organic chemistry or similar with at least 5 years of relevant professional experience in an international and highly regulated environment
• Deep expertise in chemical manufacturing processes & chemical process development for Active Pharmaceutical Ingredients (API) (small molecules, lipids or linker-payloads); experience in process validation is considered a plus
• Sound knowledge in analytical technologies for chemical entities
• Knowledge of EU / US GMP guidelines and regulatory standards
• Experience with generation of regulatory documents and regulatory filings (IND/IMPD, BLA/MAA)
• Refined colloquial and correspondence skills in English; presentation skills adaptable to all levels of internal and external 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 3928 (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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