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.

Process Development Specialist - Lyophilized Injectables

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