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.
This is an excellent opportunity for a scientist or engineer with strong technical understanding of freeze-drying processes to contribute to high-impact sterile injectable projects in a growing pharmaceutical R&D and manufacturing environment.
Main duties and responsibilities:
- 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, reconstitution time and overall process robustness.
- 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, Engineering and Regulatory Affairs.
- Design and execute development trials, collect and interpret experimental data, prepare technical reports and recommend process improvements.
- Investigate process-related deviations, support root cause analysis and contribute to CAPA and change control activities where required.
- Prepare and review process development documentation, protocols, reports, batch records and technical transfer packages.
- Contribute to the implementation of Quality by Design principles, risk assessments and continuous improvement initiatives for lyophilized injectable products.
- Ensure that all activities are performed in line with GMP requirements, internal procedures and applicable regulatory expectations.
- Stay updated on scientific and technological developments in lyophilization, sterile injectables and pharmaceutical process development.
Requirements
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Chemistry or a related scientific field.
- Minimum 8+ years of experience in process development, formulation development, technology transfer or manufacturing support for final sterile injectable pharmaceutical products.
- Hands-on knowledge of lyophilization/freeze-drying processes, including cycle development, optimization, scale-up and troubleshooting.
- Understanding of key lyophilization parameters and product quality attributes, such as collapse temperature, glass transition temperature, residual moisture, cake structure and reconstitution performance.
- Good knowledge of GMP requirements, pharmaceutical development documentation and regulatory expectations for sterile products.
- Experience with experimental design, data analysis, technical report writing and process improvement activities.
- Strong problem-solving, analytical thinking and cross-functional collaboration skills.
- Excellent command of English, both written and verbal.
- Availability to work in Athens, Greece.
Benefits
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.