Manager* CTSM GMP Operations

Open for hire at one of the following locations –  Mainz Goldgrube. - Job ID: 6793 

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 GMP Operations 

Your main responsibilities are: 

• Responsible for GMP process development and continuous improvement in Clinical Trial Supply Management (CTSM) related to secondary packaging and labeling (P&L) of investigational medicinal products (IMPs) (e.g. product specification files, clinical labels, P&L ordering, expiry update, destruction) 
• Responsible for evaluation and implementation of state-of-the-art strategies related to IMP P&L, e.g. just-in-time manufacturing, pooled supplies, process digitalization. 
• Represents CTSM as expert on IMP P&L activities in cross-functional teams 
• Represents CTSM in setup of processes with internal and external P&L CMO's including generation & maintenance of knowledge about CMOs' offered processes 
• Responsible for (coordination of) label setup for study drugs ensuring regulatory requirements and agreed milestones, quality and costs are met 
• Liaises with GMP QA and other relevant cross functional interfaces and supports on CTSM GMP activities related to IMP P&L 
• Liaises with IMP Manager to define GMP requirements for clinical trials and setup P&L processes with vendors 
• Supports on appropriate CTSM GMP risk communication and ensures CTSM GMP requirements are met 
• Provides input into Certification and Release Strategy for clinical trials (e.g., QP declaration, Sponsor release) 
• Reviews, aligns, and provides input to QAAs for internal and external CMOs  
• Coaching of less experienced team members 

What you have to offer: 

• University degree in Science, 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

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. 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!