Manager* Clinical Trial Supply Management GMP Compliance

  • Cambridge, Massachusetts
  • Mainz
  • Work experience
  • Project Management, Product Management
  • Transport
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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.

Manager* Clinical Trial Supply Management GMP Compliance

At BioNTech, you will set up complex structures to ensure efficient and timely end-to-end supply of our clinical studies with investigational medicinal products in an innovative international environment in compliance with regulatory requirements. Thereby you make an indispensable contribution to the planning and operational interface between Contract Manufacturing Organizations (internal and external) and Quality Assurance  of clinical trial materials. 
Your main responsibilities are:
  • Establishing and managing global Packaging & Labeling networks to support clinical trial supply activity as well as developing and maintaining strategic alliances with contract partners
  • Vendor relationship management and maintenance of knowledge about the processes offered by the vendor (internal and external)
  • Setting up Quality Agreements for allocated vendors to ensure the conduction of Packaging and Labelling in accordance with GMP/GCP requirements to prevent any impairment of product quality and thus any risk to patient safety
  • Setting up, optimization, harmonization and integration of global clinical trial supply Packaging & Labelling processes for Phase I-III clinical trials (e.g., Labelling and relabeling as part of expiry updates, Product Specification Files, Packaging and Release of products) across all associated functions, all applicable BioNTech´s entities, and across different product classes
  • Operational support as process expert for particular clinical trial supply activities related to Packaging & Labelling including change and deviation management
  • Maintaining inspection readiness for clinical trial supply Packaging & Labelling activities under BNT´s responsibility (Filing, deviations, CAPAs, etc.)
  • Coaching and Training

What you have to offer.

  • Professional experience in the pharmaceutical industry or biotechnology and proven track record of clinical supply chain management in global clinical trials up to Phase III
  • Knowledge in relevant legislation and international GxP guidelines with focus on GMP.
  • Professional experience in managing Packaging & Labelling activities
  • Effective stakeholder management, both in cross-functional internal and external matrix team environment
  • Independent, structured, solution-oriented and proactive way of working
  • Business-professional English language skills are mandatory, good German language skills are advantageous

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 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 4170 (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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