Associate Director* IMP Management

  • Mainz
  • Work experience
  • Project Management, Product Management
  • Transport
scheme imagescheme imagescheme image

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.

Associate Director* IMP Management

At BioNTech, you will set up complex structures to ensure efficient and timely end-to-end supply of our clinical trials with investigational medicinal products in an innovative international environment in compliance with regulatory requirements. You will 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:
  • Accountable for leading IMP Management activities, capabilities and resourcing capacity to assure efficient and compliant study medication demand forecasting, resupply planning, label design, packaging, IRT (Interactive Response Technology) set-up and distribution, destruction, drug accountability for study and comparator drugs, placebos, and ancillary supplies across multiple R&D Programs and drug platforms to meet company´s milestones, and provide guidance regarding logistics and feasibility on overall clinical development strategy
  • Lead IMP-related activities within multifunctional internal and external R&D Programs and provide guidance regarding logistics and feasibility on overall clinical development strategy (e.g. selection of countries, storage temperature, dosage form) and active contribution to clinical core documents.
  • Lead organization-wide process improvement activities related to IMP manufacturing, distribution and logistics with increasing complexity to ensure operational efficiency.
  • Responsible to lead, coordinate, and implement cross-functional standards and processes to meet multi-national GxP (GCP, GMP and GDP) compliance (processes, documents) of Clinical Trial Supply Management activities for assigned R&D Programs/platforms/ areas of responsibility.

What you have to offer.

  • Degree or vocational training in scientific or related field and several years of professional experience in the pharmaceutical industry or biotechnology and proven track record of clinical supply chain, logistics set up & management in global clinical trials up to Phase III
  • Expert knowledge in GMP, GDP, GCP and in their implementation. Proven expertise in supplying several clinical studies up to phase III with investigational medicinal products
  • Many years of experience in working with external CMOs and CROs in an international environment. Experience in the creation and adaptation of SOPs for complex processes
  • Experienced handling of MS Office and knowledge of Interactive Response Technology Systems (IRT)
  • Strong analytical and organizational skills added with very strong collaboration, team- and alignment-building skills
  • Effective stakeholder management, both in cross-functional internal and external matrix team environment
  • Excellent organization and communication skills as well as highly motivated and open-minded team player, enjoys working in a team and is able to motivate a team
  • 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, 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