Process Development Specialist - Lyophilized Injectables

About the role

DEMO S.A., one of the leading pharmaceutical manufacturers in Europe, is looking for a Process Development Specialist – Lyophilized Injectables to join its team in Athens, Greece . The role focuses on the development, optimization, scale-up and transfer of lyophilization processes for sterile injectable pharmaceutical products, supporting the successful transition from development to GMP manufacturing.

What you'll do

• Develop, optimize and support lyophilization cycles for sterile injectable pharmaceutical products, from laboratory scale to pilot and commercial manufacturing scale
• Participate in formulation and process development activities, focusing on product stability, cake appearance, residual moisture
• Evaluate critical process parameters and critical quality attributes related to freezing, primary drying and secondary drying stages
• Support scale-up, technology transfer and process validation activities in collaboration with R&D, Production, Quality Assurance, Quality Control
• Design and execute development trials, collect and interpret experimental data, prepare technical reports and recommend process improvements

What you need

• 8–14 yrs of experience
• GMP
• Chemistry
• Regulatory affairs
• Root cause analysis
• B.Tech or B.E.