Upstream Process Specialist
We are seeking a talented professional to drive innovation in biopharmaceutical manufacturing. This role offers state-of-the-art technology and a unique opportunity to work with cutting-edge equipment.
Key Responsibilities:
1. Develop and execute upstream process strategies, including media preparation and cell culture bulk drug substance manufacturing.
2. Collaborate with cross-functional teams to author and review process transfer documentation, technical protocols, and validation documents.
3. IDentify laboratory study requirements and work with Global Process Development for study design and execution.
4. Support new raw material and consumable introduction through materials lists, Bills of Materials, specifications, and testing requirements.
5. Closely work with Quality, Supply Chain, and Manufacturing Operations to ensure material availability and release.
6. Implement process improvements such as yield and cycle time reduction.
Required Skills and Experience:
1. Minimum 5+ years' experience in Technical Services/Process Development/Manufacturing Support in biological bulk drug substance manufacturing organizations.
2. Technical knowledge of multiple unit operations in cell culture processing.
3. Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
4. Advantageous experience in Technology Transfer activities.
Benefits:
This role is located near Dublin Airport and offers a dynamic work environment with opportunities for growth and development.
About the Role:
This position requires strong technical knowledge and experience in biopharmaceutical manufacturing. The ideal candidate will be able to collaborate effectively with cross-functional teams and communicate complex technical information clearly.