Manager* CTSM GCP Operations
Open for hire at one of the following locations – London, Cambridge Erie Street, Mainz Goldgrube. - Job ID: 3089
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.
Manager* CTSM GCP Operations
Your main responsibilities are:
- Supports and manages relationships with pharmacies in global clinical trials up to Phase III
- Contact for IMP-related and CTS-related questions for CROs/ Sites / pharmacies
- Contributes to training CROs and sub-contracted IMP services
- Liaises with GCP QA and supports CTSM GCP related activities
- Supports on appropriate CTSM GCP risk communication and ensures CTSM GCP requirements are met
- Manages complaints, deviations, changes, and other quality incidents for GCP topics
- Manages and coaches Specialist CTSM GCP
What you have to offer:
- Relevant professional experience (> 3 years) in Clinical Supply in Pharmaceutical or Biotech industry setting or any equivalent e.g., Pharmacy Services.
- Relevant completed university education in Pharmacy, experience as a Clinical Pharmacist or in an equivalent role.
- Proven track record of supply chain and study drug logistics (set up and management) in global clinical trials up to Phase III
- Deep Knowledge about Pharmacy Manuals / Pharmacy Questionnaires
- Deep Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
- Knowledge about standard office software proficiency (e.g., MS Office)
- Business-professional English language skills
- Self-motivated with strong problem-solving and learning skills
- Ability to create independent analyses and develop new solutions
- Excellent organizational and communicative skills
- Enjoys working in a team
- Ability to coach, mentor, and collaborate with business partners, analysts, and team members
- Openness to explore on new topics for setting up the trend
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 – London, Cambridge Erie Street, Mainz Goldgrube. Apply 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!