Senior Specialist, Technical Services

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

• The Senior Specialist Technical Services has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The Senior Technical Specialist will provide processing expertise to support the technology transfer, validation and routine commercial manufacturing for Upstream manufacturing. The Senior Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer and validation related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.

YOU WILL BE RESPONSIBLE FOR:

• Providing process expertise in Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
• Authoring and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
• Identifying requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.
• Supporting the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
• Working closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
• Identifying and implement process improvements, e.g., yield, cycle time reduction.
• Generating documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
• May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
• Providing on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
• Leading any key process changes using change control system.
• Adhering to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
• Ensuring compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.
• Authoring and reviewing common technical document (CTD) sections and reports for regulatory agency submissions.
• Serving as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.