Lead Analytical Scientist

Job summary

This role involves leading late-stage analytical development for peptide-based medicines, providing scientific and technical direction across various Development and Life Cycle Management projects. The position requires effective coordination with external partners, particularly Contract Development and Manufacturing Organizations (CDMO).

Qualifications

• M.Sc/PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field
• Extensive experience in the Pharmaceutical Industry focusing on analytical science or quality control, including technical leadership or mentoring roles
• Knowledge of GMP and regulatory aspects related to late-stage analytical CMC development
• Experience with outsourcing to Contract Manufacturing Organizations (CMO) and Contract Research Organizations (CRO)
• Familiarity with late-stage analytical development, validation, and Life Cycle Management support, preferably for peptide-based products
• Proven ability to lead cross-functional project teams with strong collaboration and stakeholder management skills

Responsibilities

• Oversee analytical late-stage development and support activities in Development and Life Cycle Management projects
• Provide scientific and technical leadership, mentoring team members and promoting best practices
• Support Drug Substance and Drug Product development through analytical activities, including stability programs and specifications
• Manage collaboration with CDMO, ensuring effective communication and method transfer
• Prepare scientific reports and documentation for pharmaceutical products
• Contribute scientific input to regulatory documents in collaboration with colleagues and CDMO

Skills

• Strong analytical mindset with ownership of complex initiatives
• Excellent communication skills across teams
• Proactive problem-solving approach
• Ability to mentor and guide colleagues

Education

• Advanced degree (M.Sc/PhD) in relevant scientific fields

Tools

• Familiarity with analytical tools and methodologies relevant to pharmaceutical development