Specialist* IMP GxP Compliance

  • Mainz
  • Work experience
  • Project Management, Product Management
  • Quality Management, Quality Assurance
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Become a member of the BioNTech Family!

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
 
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.

Specialist* IMP GxP 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 Clinical Operations, R&D Program Management, Quality Assurance and GMP Manufacturing of clinical trial materials. Your main responsibilities are:
  • Support GxP compliance of all clinical trial supply management and drug-related storage and distribution activities in global Phase I-IV clinical trials from drug product manufacture to on site disposal
  • Responsible for project-related/project-independent GxP documentation and filing thereof as well as maintenance of lists
  • Operational support and independent performance of operational tasks as process expert in the IMP GxP Compliance Team across diverse clinical trials and R&D Programs (e.g. Batch Record Reviews, Sponsor Release, Temperature Excursion Tracking and Assessment, TMF Filing etc.)
  • Involved in establishing and maintaining inspection readiness for clinical trial supply activities under BNT`s responsibility (Action Tracker, training status, filing, deviations, CAPAS, etc.) and support in preparing, accompanying and following up on internal and external audits/inspections (collaboration partners, competent authorities; GMP and GCP) 
  • Contribution to the set-up and optimization of processes and workflows (e.g. support in the creation and review of SOPs, Templates, Manuals, Logs and other GxP related documents)

What you have to offer.

  • Successfully completed university degree or a comparable education, ideally with a scientific focus connected with several years of professional experience
  • Experience in pharmaceutical, logistic or biotech industry 
  • Knowledge of quality standards (GMP, GCP, GDP) and regulatory requirements for manufacturing, packaging, storage and distribution of clinical trial samples in an international environment
  • Profound skills in the application of configurable standard software (e.g. MS Office) as well as a quality management systems 
  • Fluency in English as well as exceptional communications skills, 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, Vanessa Hauk will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).

*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.

BioNTech - As unique as you

https://biontech.de