Senior Drug Product Specialist

Job summary

The role involves leading formulation development for injectable products from early research through to Phase 2, focusing on fixed-dose combinations. The specialist will collaborate closely with contract manufacturing organizations and Regulatory Affairs to ensure timely delivery and compliance.

Qualifications

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

Responsibilities

• Lead formulation development for injectables, including design of experiments (DoE), excipient compatibility assessments, and stability strategies
• Design drug product manufacturing processes and define scale-up strategies with phase-appropriate controls
• Plan and execute lab-scale formulation experiments, characterization, and troubleshooting
• Provide input to drug product manufacturing plans to ensure clinical supply readiness
• Conduct product and process risk assessments in collaboration with CMOs
• Define and execute primary packaging selection

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 formulation development tools and methodologies