Process Development Specialist - Lyophilized Injectables

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.

Work arrangement
No