Lead/Principal Scientist (Biotechnology)

Gladsaxe Municipality, Capital Region
Posted 2 days, 4 hours ago
Research and Development

About the role

Job summary

The role involves leading formulation development for monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) from early research through Phase 2, ensuring patient-ready medicines. The position requires close collaboration with internal and external partners to align on manufacturing and regulatory strategies.

Qualifications

  • MSc/PhD in chemistry, biochemistry, protein sciences, immunology, or a related field
  • Minimum 5 years of experience in formulation development for antibody-based medicines (mAbs and/or ADCs) up to Phase 2
  • Experience with antibody-drug conjugates
  • Familiarity with Good Manufacturing Practice (GMP) and regulatory aspects of Chemistry, Manufacturing and Controls (CMC) work
  • Practical experience with drug product manufacturing and tech transfer, including outsourcing to contract manufacturing organizations (CMOs)
  • Willingness to work hands-on in the laboratory when necessary

Responsibilities

  • Lead formulation development including biophysical characterization for mAbs and ADCs from early research to Phase 2
  • Design drug product manufacturing processes and define scale-up strategies aligned with phase-appropriate controls
  • Plan and execute lab-scale formulation experiments, characterization, and troubleshooting for antibody and ADC candidates
  • Provide input to drug product manufacturing plans covering purpose, timing, and batch size to secure clinical supply readiness
  • Lead product and process risk assessments in collaboration with CMOs, including bioconjugation and fill-finish partners
  • Provide input to drug substance/drug product specifications

Skills

  • Strong collaboration and communication skills across functions
  • Ability to balance speed with quality in early development
  • Focus on patient needs, compliance, and timelines

Education

  • MSc/PhD in relevant scientific fields

Tools

  • Experience with laboratory equipment and techniques relevant to formulation development
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