Specialist* CTSM GCP Operations
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 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
- Participates in pharmacy trainings
- Defines structure of Investigator meeting documents
- Provides input into monitoring manuals
- 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 in supply chain and study drug logistics in global clinical trials up to Phase III
- Knowledge about Pharmacy Manuals / Questionnaires
- Medical writing skills
- Comprehensive Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
- 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:
- Flexible Working Time
- Mobile Office
- Work from EU Countries
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube, Cambridge Erie Street, London 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 5536 (please indicate for inquiries)
We look forward to your application!
*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!
BioNTech - As unique as you
www.biontech.com