Manager* CTSM GMP Operations
Become a member of the BioNTech Family!
As a part of our team of more than 4.000 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.
Your main responsibilities are:
- Represents CTSM in setup of processes with internal and external CMO's including generation & maintenance of knowledge about CMOs' offered processes
- Reviews, aligns, and provides input and maintains QAAs for internal and external CMO
- Provides input into Certification and Release Strategy for trial (e.g., QP declaration, Sponsor release)
- Represents CTSM as expert on DP manufacturing activities
- Liaises with GMP QA and other relevant cross functional interfaces and supports on CTSM GMP related activities
- Liaises with Logistics to plan return process
- Liaises with IMP Manager to define P&L requirements for trial and conduct P&L planning with vendors
- Supports on appropriate CTSM GMP risk communication and ensures CTSM GMP requirements are met
- Generates/coordination of labels for study drugs ensuring agreed milestones, quality and costs are met
- Coaching
What you have to offer:
- University degree in Engineering, Supply Chain Management or related discipline
- Multiple years of work experience in Clinical Supply in Pharmaceutical or Biotech Industry setting or other relevant professional experience in Packaging and Labeling
- 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 GMP Principles (SOPs, Documentation, etc.) and Deep Understanding of Quality Management Systems
- Advanced knowledge in preparing for and participating in audits and inspections
- Understanding of Planning & Scheduling processes
- Knowledge about contract settings
- Knowledge about IRT systems and standard office software proficiency (e.g., MS Office)
- Effective stakeholder management
Benefits for you:
We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
How to apply:
Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.
Please note:
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected.
- Please note that BioNTech will run a background check during the hiring process
We are looking forward receiving your application.
*BioNTech does not differentiate on the basis of 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!
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www.biontech.com