Technical Services Upstream Lead

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The Technical Services Commercial Upstream Associate Director has primary responsibility for upstream mammalian cell culture process performance for all current and future products in commercial manufacturing within Bulk Drug Substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. This includes supporting upstream commercial manufacturing campaigns and oversight of Continued Process Verification for commercial processes in the Dublin facility. The person will be required to work in close collaboration with Operations, Engineering, Quality, Supply Chain, Quality Control, Regulatory and other involved departments to provide successful process support. The person should have proven experience leading a commercial technical services team involving Cell Culture Processes, Driving Process Improvements, Leading Investigations, Continued Process Verification (CPV), Risk Assessment (using QRM tools), and building strategies / SME capability.

YOU WILL BE RESPONSIBLE FOR:

• To provide leadership to a team of approximately 6-8 Technical Specialists responsible for supporting multiple commercial upstream unit operations.
• To ownership of delivery of process documentation, technical protocols and reports, and validation documentation, strategy documents.
• To identify requirements for laboratory studies to support process decisions or validation activities, and to liaise closely with Process Development / MSAT to oversee the design and execution of studies.
• Raw materials and consumables lifecycle management for existing product.
• Providing leadership of a team of technical SMEs to deliver successful commercial batches.
• To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet routine manufacturing timelines.
• Capture and verify batch data and own the Upstream continued process verification (CPV) programme across all products, to ensure appropriate control limits are in place and trends and causes of variability are identified and acted upon.
• Collate and report process data for assigned relevant chapters for all annual product quality reviews (APQR) for BDS cell culture and harvest processes.
• To serve as a subject-matter expert (SME) on Upstream unit operations and process support during regulatory submission and agency inspections.
• Use data analytics tools (e.g., Simca, Discoverant) to analyse continuous and non-continuous process data to identify and implement process improvements as part of routine manufacturing, e.g., yield improvement and Cost of Goods (COG) improvements.
• To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
• Provide technical input for technology transfer of future commercial products into ADMF.
• Oversight of Upstream Process Performance Qualification (PPQ) execution of new products transferred into ADMF.
• May be required to work periodically out of normal business hours (temporary shift working) during periods of batch execution and provide on-call support to manufacturing.
• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
• Lead any key process changes using change control system.
• Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.
• To author and review common technical document (CTD) sections and reports for regulatory agency submissions.