Manager* CTSM IMPM (individualized mRNA cancer vaccines) in Mainz bei BioNTech AG

BioNTech AG

Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, Gaithersburg 930 Clopper Road, London. - Job ID: 6099

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 IMPM (individualized mRNA cancer vaccines)

Navigating Global clinical Trial supply for individualized therapies: A IMPM’s Key Role in Personalized Therapies

In the area of personalized therapies, every patient journey is unique and pivotal. Explore how a dedicated IMP Managers orchestrates global trials with focus on delivering individualized products to each patient. By coordinating and steering trial supply chain activities ,seamless logistics and trial execution they empower patients worldwide to access individualized treatments and advancing the frontier of personalized medicine.

Your main responsibilities are:

Collaborate with external/internal stakeholders to improve clinical trial operations.
Coordinate with CMC on product characteristics (volume/concentration)
Collaborate with GCP Compliance to conduct CRO training.
Translate clinical forecasts into kit needs/patient units and clinical needs
Collaborates with CTSM functions (logistics, GxP, IRT) to determine trial design
Share relevant trial-specific information with internal functions (e.g., planning, GMP operations, VM, IRT systems, logistics)
Responsiblity for the execution of assigned clinical programs/studies
Define trial design based on input from CTSM functions.
Ensure that the trial design is followed across functions
Provide trial specific input to process experts to support preparation of trial specific documents (e.g. Pharmacy Manual)

What you have to offer:

Completed university education in supply chain management, pharmacy, chemistry, biotechnology, biochemistry, or a related discipline
Relevant professional experience in clinical trial supply management or project management in the pharmaceutical or biotechnology industry, ideally in the areas of ClinDev, ClinOps or Clinical Supply
Proven experience and track record in clinical trial management
Knowledge of GCP principles (e.g., ethical principles, appropriate drug information, etc.)
Knowledge of GMP principles (SOPs, documentation, etc.)
Knowledge of IRT systems and standard office software (e.g. MS Office).
Project management skills
Very good English language skills
Ability to solve multi-layered and dynamic tasks
Self-motivation with strong problem solving and learning skills
Ability to work accurately under pressure in a diverse environment
Willingness and ability to take on responsibility and personal responsibility

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 930 Clopper Road, London. 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, healt