Critical Reagents Specialist
What are your responsibilities?
- Support transfer of BCRs of new Biological products from our Manufacturing Division Commercialization / our Research Laboratories to Biotech BCR Hub
- Support complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of BCRs within the global Biologics franchises
- Support distribution (in time delivery) of BCRs to laboratories, contract laboratories and regulatory agencies
- Provide bioanalytical support to our Manufacturing sites, Laboratories and other functional groups as needed
- Provide bioanalytical support in responding to regulatory questions, authoring appropriate CMC sections or appropriate technical support during regulatory inspections
- Conform to current Good Manufacturing Practices (cGMP) as they apply to the functions of the group
- Support/drive required GMP/GLP activities like change requests, deviation notifications/management.
Who are we looking for?
- Bachelor’s/ Master’s degree in Biology, Chemistry, Biochemistry, or a related biological science
- Experience (1–2 years for a Master’s and 2-4 years for a Bachelor’s degree) in the areas general biochemistry, analytical biochemistry or immunochemical techniques
- A thorough understanding of Bio-analytical methods (Elisa, HPLC, CE-SDS) and validations
- Basic to strong technical knowledge and a high level of technical performance
- Ability to achieve productivity by managing time, priorities and personal effort in a fast-paced environment. Additional requirements
- Strong understanding of GLP/ GCP/ GMP regulations, with the ability to apply these practices daily
- Statistical Analysis experience with familiarity with JMP or Minitab
- Strong ability to work either independently as well as in teams and the ability to coordinate activities for multiple projects as needed to meet timelines
- Strong project management skills, innovative abilities and strong drive to improve (preferably Green Belt certification)
- Strong persuasive and influencing skills
- Strong written and oral communication skills (in both English and Dutch).
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.