Upstream Technical Services Senior Specialist

<p><b>This is what you will do:</b></p><p>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 and/or Downstream 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 vaklidation related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Cleaning Validation, Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.</p><p></p><p><b>You will be responsible for:</b></p><ul><li>To provide process expertise in one, or both of the following disciplines:<ul><li>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 <span>centrifugation/clarification.</span></li></ul></li><li>To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents</li><li>To identify 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</li><li>To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements</li><li>To work 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</li><li>Leading operational process improvements using Lean Tools  </li><li>To identify and implement process improvements, e.g. yield, cycle time reduction</li><li>To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale</li><li>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.</li><li>To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution</li><li>Lead any key process changes using change control system</li><li>Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits</li><li>Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.</li><li>Author and review technical documentation (Technical assessments, protocols and reports, and strategy documents) as well as Regulatory CTD review</li><li>To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.</li></ul><p></p><p><b>You will need to have:</b></p><ul><li>Bachelor’s Degree or Higher in a Scientific or Engineering discipline with previous experience (e.g. min 5 years). Alternatively, significant operational or technical experience in a GMP environment will be considered.</li><li>Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.</li><li>Engage in continual improvement through assessment and use of new PAT technologies.</li><li>Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.</li><li>Experience interpreting and guiding team members around principles and concepts appropriate to the role within a regulated environment</li><li>Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.</li><li>Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.</li><li>Ability to drive for results independ