Associate Director* CTSM GMP Operations
Open for hire at one of the following locations – Singapore. - Job ID: 6082
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.
Associate Director* CTSM GMP Operations
Your main responsibilities are:
- Own and write CTSM GMP related SOPs
- Define shelf-life extension and re-labeling strategy
- Define and lead implementation of CTSM GMP function process initiatives
- Define and implement performance objectives for CTSM GMP function
- Drive process alignment/harmonization with internal and external CMOs (e.g., P&L, Inventory Management)
- Drive CMO Performance Management
- Support QA in Audits for P&L CMOs
- Manage performance management for CTSM GMP function
- Responsible for appropriate CTSM GMP risk communication and ensure CTSM GMP requirements are met
- Ensure clinical projects are sufficiently supported and provide CTSM GMP advice
- Train new team members to follow SOPs in CTSM GMP
- Ensure CTSM GMP SOPs are followed
What you offer:
- A completed university education in Engineering, Supply Chain Management or Operations/Quality or related discipline Broad and/or in-depth and special task-specific expertise and skills
- Relevant professional experience in Clinical Supply in Pharmaceutical or Biotech industry setting or other relevant professional experience in Packaging & Labeling
- Proven track record of supply chain and study drug logistics (set up and management) in global clinical trials up to Phase III
- Deep Understanding of Quality Management Systems
- Deep Understanding of contract settings
- Deep Knowledge about GMP Principles (SOPs, Documentation, etc.)
- Experience in supporting audits & inspections for CMO
- Experience in compilation and coordination of regulatory documents
- Knowledge about Planning & Scheduling processes
- Knowledge about IRT systems and standard office software proficiency (e.g., MS Office)
- Business-professional English language skills
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 – Singapore. 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!