Scientist Monoclonal Antibody Process Development

Merck Merck · Pharma · North Brabant, Netherlands

Scientist role focused on the development, improvement, and troubleshooting of monoclonal antibody processes, including upstream (cell culture) and downstream (purification) operations, within a global Centre of Excellence. Requires hands-on industry experience and knowledge of GxP guidelines.

What you'd actually do

  1. Design, plan and execute laboratory experiments (USP, DSP and formulation based on QbD) in alignment with project goals and guidelines.
  2. Collaborate closely with project leads and cross-functional teams to define study designs and coordinate supporting activities.
  3. Analyze, interpret and document experimental results; share insights and contribute to data-driven decision-making.
  4. Identify deviations, investigate root causes and recommend improvements to processes, methods or study designs.
  5. Prepare clear and concise technical documentation (e.g., protocols, reports and memos) in English.

Skills

Required

  • Bachelor's or Master's degree in biotechnology, bioprocess technology, or a related field
  • Relevant hands-on industry experience in mAb process development
  • Working knowledge of laboratory setup, operations and regulatory requirements
  • Proficiency in English, both written and spoken
  • Experience with GxP guidelines and compliant ways of working
  • Familiarity with Manufacturing Process Sciences (MPS) methods and practices
  • Assay Development
  • Cell Culture Techniques
  • Data Management
  • Detail-Oriented
  • Flow Cytometry
  • Good Laboratory Practices (GLPs)
  • Immunoassays
  • Manufacturing Processes

Nice to have

  • Master's degree preferred
  • preferably 5 years working with bioreactors and/or purification and formulation

What the JD emphasized

  • GxP guidelines
  • GLP/GMP requirements