Specialist, Clinical Trial Supply Management, 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.
Responsibilities:
- Liaises with logistics to plan return process
- Liaises with logistics to set up DP shipments to CMOs and to release kits to clinical depots
- Responsible for order management for P&L
- Creates Label generation including documentation (internal and external)
- Coordinates (e.g., QP) release and compiles necessary documents
- Conducts shelf-life extension and re-labeling
- Has authorization for destruction at CMO (IMP, Labels etc.)
- Conducts returns & destruction
- Checks invoices
- Creates KIT PSF
- Supports on managing complaints, deviations, change and other quality incidents for GMP topics
- Maintains Phrase Library for English Master label
- Writes and updates SOP
Requirements:
- Relevant completed university education in Engineering, Supply Chain Management or related discipline or technical quality related vocational training
- Relevant professional experience (usually <3 years) in Clinical Trial Supply Management in pharmaceutical or biotech industry setting/other relevant professional experience, such as operations, packaging & labelling management
- Experience in 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.)
- Function holder (First name and last name) Click or type here to enter text.
- Knowledge about Quality Management Systems · Knowledge about preparation of audits and inspections
- Knowledge in support of compilation and coordination of regulatory documents · Basic Planning & Scheduling Knowledge
- Standard office software proficiency (e.g., MS Office)
- Business-professional English language skills
Preferred Skills:
- Well self-organized way of working
- Self-motivated with problem-solving and learning skills
- Ability to solve complex activities that do not follow comparable patterns
- Very reliable and diligent way of working · Able to adapt and develop solutions
- Good communication skills
- Openness and curiosity to explore on new topics for setting up the trend
- Enjoys working in a team
- "Can do” attitude, paired with healthy pragmatism
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