Director* CMC Personalisierte Medizin

  • Mainz
  • Work experience
  • Project Management, Product Management
  • Research, development, teaching
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 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.

CMC Expert* Personalized Medicine

The CMC Expert* will play a key role in leading complex development projects in pre-clinical to clinical stage projects focusing on personalized medicine. The CMC Expert* will be accountable for defining CMC strategies within the sub-projects, creating integrated CMC project plans, tracking progress, identifying and managing risks, and communicating across all levels of the organization. As CMC-Subteam leader, the CMC Expert* will represent the CMC-team in the respective program team and will bridge the clinical projects with the drug substance and drug product development and analytical development work within the organization. Based on the CMC development strategy of the company, the CMC Expert* will provide strategic and scientific input in the assigned development programs. In addition, and if applicable, the CMC Expert* will serve as the liaison and key contact for Contract Development and Manufacturing Organization partners associated with the development projects.

Your main responsibilities are:
  • Collaborate with technical leads and expertise areas (Process Development, Analytical Development, Quality, Regulatory, Engineering, Automation, Supply Chain, Commercial) to develop detailed CMC project plans required to successfully progress an asset from pre-clinical through clinical phases
  • Lead the scientific assessment of development programs related to all CMC aspects as the CMC project lead
  • Manage CMC timelines and budget; bring focus to risk management activities and implement processes to identify risks, maintain risk registry and proactively execute mitigation plans to help ensure effective program execution
  • Promote timely and data-driven decision making, and facilitate strategic discussions within CMC and with external partners to inform product development
  • Drive continuous improvement of process and data quality, through streamlining and optimizing processes; automation; and digitalization

What you have to offer.

  • Advanced degree in Science with at least 10 years of relevant industry experience in biologics/technology development, preferably in a crossfunctional setting
  • Experience in the field of personalized medicine and/or equipment/device development would be a strong plus
  • Prior experience in project leadership or people management paired with the ability to engage cross-functional teams
  • A regulatory background for clinical stage or marketed biological products would be a strong plus

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location  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 7121 (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!

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https://biontech.de