Parenterals Tech Transfer Manager

Corporate Role MS&T CMO Management

Our customer is a major player in the biopharmaceutical industry offering a wide range of globally established and recognized products. The new position of a Manager for Sterile Drug Product requires significant experience in manufacturing compounding and filling of sterile drug products in vials prefilled syringes and cartridges.

Support the young team of Global External Manufacturing in this challenging corporate role!

Your expertise:

• Subject matter expert (SME) in sterile manufacturing processes
• Support the process capability analysis and Continuous Process Verification of key quality attributes and parameters at the different CMOs
• Provide Impact assessments of change requests
• Manage manufacturing or complaint investigations on product impact including root cause analysis CAPA generation and impact assessment

You have in depth technical knowledge of sterile manufacturing technology and processing techniques.

Your abilities:

• Able to work within and lead crossfunctional technical teams across multiple cultures
• Experienced in deviation investigator and GMP change management in sterile commerical production of drug product

You identify and execute process robustness improvement projects where required. Using this information and knowledge to contribute to comprehensive and accurate annual product reviews as well as performance assessment of CMOs.

Your skill profile:

• scientific or engineering degree
• 24 y experience in commercial manufacturing of sterile drug products
• Experience in parenteral compounding and filling
• Involvement in deviations CAPAs and risk assessmets (FMEA)
• Understanding of process engineering analytical and regulatory aspects of sterile drug product manufacturing

Your solutionoriented approach allows you to communicate and negotiate in an effective way. Your English is fluent. The position requires occasional level of travel.