Manager* IMP GDP Compliance

  • Cambridge, Massachusetts
  • Mainz
  • Work experience
  • Purchasing, Materials Management, Logistics
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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* IMP GDP 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, Clinical Operations, Global Customs, CMC and Quality Assurance. Your main responsibilities are:
  • Establishing and managing global distribution networks to support clinical trial supply activity as well as developing and maintaining strategic alliances with contract partners for transportation brokerage, storage and distribution
  • Vendor relationship management and maintenance of knowledge about the processes offered by the vendor
  • Setting up Quality Agreements for allocated vendors to ensure the conduction of transport of clinical trial material in accordance with material and GDP requirements to prevent any impairment of product quality and thus any risk to patient safety
  • Setting up, optimization, harmonization and integration of clinical trial supply logistics processes (e.g., Temperature Excursion Handling, transport including import/export services, custom requirements, classification/safety of goods for transports) across all associated functions, all applicable BioNTech´s entities, and across different product classes
  • Set up global logistics processes for Phase I-III clinical trials from Drug Product shipment, storage at depots/sites and return for disposal
  • Operational support as process expert for particular clinical trial supply activities related to storage and distribution/logistics and in addition oversees a variety of logistics issues and is responsible to receive reports on excursions or deviations that may occur during shipment handling and storage of clinical trial material
  • Maintain inspection readiness for clinical trial supply logistic activities under BNT`s responsibility (Filing, deviations, CAPAs, etc.)
  • Coaching and training

What you have to offer.

  • Supply Chain Management, Natural sciences, or technical background (university degree or successfully completed apprenticeship with experience in GDP related profession or similar) with several years of professional experience
  • Experiences in cold chain logistics and handling of temperature deviations
  • Knowledge  in relevant legislation and international GxP guidelines with focus on GDP
  • Profound skills in the application of configurable standard software (e.g. MS Office, especially Excel) as well as a quality management systems 
  • Independent, structured, solution-oriented and proactive way of working
  • Exceptional communication as well as organizational skills with a fluency in  English, spoken and written

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 7464 (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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