Lead/Principal Scientist (Biotechnology)

Job summary

The role involves leading formulation development for monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) from early research through Phase 2. The position requires collaboration with internal and external partners to ensure timely delivery of clinical supplies.

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

Skills

• Strong 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