02 Oct
|
Demo
|
Hyderabad
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 workplace.
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,
📌 Process Development Specialist (Hyderabad)
🏢 Demo
📍 Hyderabad