# Process Development Specialist - Lyophilized Injectables

**Company:** [Demo S.A.](https://jobs.workable.com/companies/bfFZ3SuxMR5zjdkBWmB1yU.md)
**Location:** Athens, Greece
**Workplace:** on site
**Employment type:** Full-time
**Department:** Production & Packaging

[Apply for this job](https://jobs.workable.com/view/760252a7-07ee-4262-bc27-4a1e8f47b04a)

## Description

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.
