Specialist* CTSM GCP Operations

Open for hire at one of the following locations –  Mainz Goldgrube, Cambridge Erie Street, Gaithersburg, London. - Job ID: 7012 


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.


Specialist* CTSM GCP Operations 


Your main responsibilities are:

  • Supports cross-functional preparation of trial-specific IMP Manuals, Pharmacy Questionnaires and training material for IMP handling instructions
  • Files and maintains overview of CTSM documents that need to be filed in TMF
  • Supports resolution of IMP handling queries 
  • Provides input into monitoring manuals and other GCP-related documents
  • Supports on managing complaints, deviations, changes, and other quality incidents for GCP topics
  • Writes and updates SOPs


What you have to offer.

  • Relevant completed university education in Pharmacy, Chemistry, Biotechnology, Biochemistry or related discipline or vocational training in Pharmacies or Hospital
  • Relevant professional experience (usually <3 years) in Hospital / Pharmacy settings, Clinical Supply in Pharmaceutical Biotech industry setting, or other relevant professional experience
  • Experience with TMF management and electronic filing systems 
  • Knowledge about Pharmacy Manuals / Questionnaires
  • Medical writing skills
  • Comprehensive Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
  • Understand of supply chain and study drug logistics in global clinical trials up to Phase III
  • Standard office software proficiency (e.g., MS Office)
  • Business-professional English language skills
  • Good communication skills
  • Openness and curiosity to explore on new topics for setting up the trend
  • Ability to solve complex activities that do not follow comparable patterns
  • Very reliable and diligent way of working
  • Able to adapt and develop solutions
  • Enjoys working in a team


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 and 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 Goldgrube, Cambridge Erie Street, Gaithersburg, LondonApply 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!