Scientist

• Design and manage stability studies, including preparation of protocols, reports, and regulatory documentation
• Analyse stability data, identify trends, and provide scientific recommendations to support decision-making
• Support production and integrate stability considerations into manufacturing activities
• Contribute to investigations, deviations, and regulatory submissions related to stability
• Drive continuous improvement initiatives and identify opportunities to optimise processes
• Assess the necessity and evaluate the outcomes of stability studies
• Support stability activities for life-cycle management products and products transitioning from development to production

Development Scientist

• Support process development, technology transfer, process implementation, validation, and process optimisation activities for synthetic peptides throughout the product life cycle
• Act as subject matter expert for synthetic peptide manufacturing processes
• Support technology transfer, validation activities, and lifecycle management initiatives
• Provide scientific and technical support to CMOs and manufacturing sites
• Troubleshoot, handle deviations, optimise processes, and implement process improvements
• Serve as process and product owner for SPPS-based peptide manufacturing processes
• Prepare and review technical and GMP documentation for validation, regulatory submissions, process changes, and lifecycle management
• Support assessment, onboarding, and implementation of new CMOs
• Collaborate with Late-Stage Development, Analytical Functions, Quality Assurance, Regulatory Affairs, Global Contract Manufacturing, Sourcing, pilot facilities, production sites, and external partners
• Travel approximately 10–20 days annually