29 Oct
|
DEMO Pharmaceuticals
|
Hyderabad
29 Oct
DEMO Pharmaceuticals
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 robust 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 (Hyderabad)
🏢 DEMO Pharmaceuticals
📍 Hyderabad