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Location

Darmstadt | Germany

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Job description

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.

Scientist* Manufacturing-Linker-Payload-Chemistry

As 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.

Aufgaben:

• 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

Qualifikationsprofil:

• 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:

• 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.

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Job tags

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Salary