1. QbD
2. Belgium
3. Clinical, Qualification & Validation, Quality management
Table of Contents
Are you an expert within Advanced Therapy Medicinal Products (ATMPs) and passionate by helping companies in this area in their growth? Apply now for the job of ATMP specialist at QbD!
As a QbD ATMP specialist you will be working on several project s and you will become a member of our ATMP core team. You are a communicative versatile person, capable of solving problems, investigating root causes and implementing changes.
What do we expect from you as a ATMP Specialist?
4. Provide scientific input into development strategies for ATMPs and other biological products
5. Lead & participate in project teams, manage projects (scope, timelines, budget), and manage CDMOs (on behalf of clients)
6. Perform Due Diligences and GAP analyses of the (analytical) data of candidate drugs and advise on next steps
7. Participate in multidisciplinary Drug Development teams
8. Author and review CMC. Qualification and Validation plans, protocols and reports
9. We expect you to follow regulations on ATMP’s and share your insights/knowledge within the QbD team and at our customers
10. Provide hands-on and technical support to the manufacturing of Cell- and Gene Therapy products for clinical trials
11. Act as expert in Cell- and ex vivo Gene-Therapy.
Who are we looking for?
12. Scientific master’s degree: engineer (bio, industrial, civil), industrial pharmacist, …
13. Experience in the life science industry and preferably in ATMP projects
14. Experience in plasmid and cell banking (master cell bank, working cell bank, cell line development) and process development including scale-up/ scale-down principles is required ( upstream and/or downstream processing)
15. Experience in gene therapy manufacturing is an asset
16. Experience in clinical development (Phase I/II)
17. Knowledge of cGMP manufacturing guidance and experience with technical investigations and root cause analysis.
18. Good project management skills
19. A true QbD’er can be recognised by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challengeHungry for knowledge: You are always open to learningNo BS mentality: you can be straightforward in a respectful wayInnovative: You are constantly looking for new and better solutions(Not too) serious: your job is serious, but you don’t take yourself too serious
What does QbD Group offer you?
An attractive and complete salary package:
20. A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.
But most of all…
21. We offer sustainable careers and meaningful connections
22. We are a knowledge-based company
23. You’ll work for an award-winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, …
Our promise to you:
24. As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
25. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals .
26. In short … We stand for JPEG : J oy in P artnership, going for the E xtra mile to G et things done!
Interested?
Send us your CV and motivation letter and who knows, maybe you’ll find your #QbDream job.