Process Development Specialist - Lyophilized Injectables

About the role

Demo S.A., one of Europe's leading pharmaceutical manufacturers, is looking for a Process Development Specialist for lyophilized injectables in Athens, Greece. The role covers the development, optimization, scale-up and transfer of freeze-drying processes for sterile injectable products, supporting their move from development to GMP manufacturing. It suits a scientist or engineer with strong technical knowledge of freeze-drying.

Key responsibilities

• Develop, optimize and support lyophilization cycles from laboratory scale to pilot and commercial scale.
• Take part in formulation and process development, focusing on stability, cake appearance, residual moisture, reconstitution time and process robustness.
• Evaluate critical process parameters and quality attributes for freezing, primary drying and secondary drying.
• Support scale-up, technology transfer and process validation with R&D, Production, QA, QC, Engineering and Regulatory Affairs.
• Design and run development trials, analyse data, write technical reports and recommend improvements.
• Investigate process deviations, support root cause analysis and CAPA and change control.
• Prepare and review development documentation, protocols, batch records and transfer packages.
• Contribute to Quality by Design, risk assessments and continuous improvement, and ensure GMP compliance.

Required profile

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Chemistry or a related field.
• Minimum 8+ years of experience in process development, formulation development, technology transfer or manufacturing support for sterile injectables.
• Hands-on knowledge of lyophilization, including cycle development, optimization, scale-up and troubleshooting.
• Good knowledge of GMP, development documentation and regulatory expectations for sterile products.
• Experience with experimental design, data analysis, technical reporting and process improvement.
• Excellent written and spoken English and availability to work in Athens.

What we offer

• Competitive salary and benefits.
• Continuous specialized training and career development.
• A friendly working environment.