Einleitung(Senior) CMC Expert* as (Associate) Director* Materials
Become a member of the BioNTech Family!As a part of our team of more than 2.500 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.
(Senior) CMC Expert* as (Associate) Director* Materials
You will be responsible for leading and coordinating all technical and regulatory aspects of raw materials and excipients for development projects within the BioNTech pipeline.
Collaborate with research and development teams in definition of raw materials and excipients for the development programs
Within the procurement process, lead the technical evaluation of potential sources of material, provide specifications for materials and perform quality assessment of materials
For second supplier define processes to ensure technical equivalence of materials and regulatory acceptance of all suppliers
Drive continuous improvement of processes for assessment and procurement of raw materials and excipients
An Advanced Degree (Master of Science/PhD) in Pharmacology, Chemistry, Biopharmaceuticals, or Biochemistry with several years of professional experience in an international, pharmaceutical environment
Sound knowledge of different scientific/technical CMC development functions including GMP requirements (eg pharmaceutical and/or analytical development, manufacturing)
Experience in CMC regulatory affairs would be a plus
Hands on experience working in a quality function with good understanding of all stages of drug development
Experience with regulatory filings (IND/IMPD, BLA/MAA) is considered a plus
Management skills and assertiveness
Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management
Company Pension Scheme
... and much more.
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