Associate Director CTSM IMPM

Open for hire at one of the following locations –  Mainz Goldgrube. - Job ID: 7374 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 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.


 

Associate Director CTSM IMPM 

 

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

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz GoldgrubeApply now for your preferred job and location through our careers site.


*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!