MSAT Senior Specialist, Purification-14640

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The MSAT Specialist (Purification) will shape the start-up of the new MSAT Labs at College Park

You will work on the following areas

• Generation of documents supporting lab start-up, protocols and reports for lab model and study execution
• Complete technology transfer of lab models, design of experiment and execution to completion supporting continual improvement and process improvements.
• Implement systems for the labs, ensuring the highest lab safety standards are observed

YOU WILL BE RESPONSIBLE FOR:

• Design and perform studies to support the robustness, process optimization, and characterization of the manufacturing processes, while assessing continual improvements, new material and technology introductions, feasibility assessments that support yield/process improvement initiatives and cost of goods improvement projects that can be replicated robustly at commercial scale, in line with regulatory and commercial manufacturing requirements, including industry standard methodologies.
• Perform dropout studies from large scale engineering and technical batches, growing process knowledge, providing recommendations, and problem solving to increase probabilities of technical success, while minimising technical risks.
• Perform testing using separation technique, such as HPLC, to support manufacturing process and/or MSAT studies.
• Provide technical expertise and troubleshooting for manufacturing processes. Design and co-ordinate experiments which support process investigations, and resolution of Cell Culture/Purification process deviations, root cause analysis, and CAPAs to support commercial operations, and studies in support of regulatory changes.
• The candidate must possess critical thinking skills, being entrepreneurial, with an ability to integrate data and information to tackle complex problems to maintain robust and improved manufacturing processes. Effectively communicate complex ideas to audiences with varying degrees of knowledge
• Maintain knowledge and history of the products & process throughout the entire commercial lifecycle, including development history