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.