Senior Specialist, Upstream Technical Services (12 months Fixed Term)

​​Position Summary​

​​The Senior Specialist Technical Services has primary responsibility insupporting the cGMP manufacture of biological bulk drug substance(BDS) at Alexion’s facility in Blanchardstown, Dublin. The SeniorTechnical Specialist will provide processingexpertiseto support thetechnology transfer,validationand routine commercial manufacturingfor Upstream manufacturing. The Senior TechnicalSpecialist will be required to work in closecollaboration with Process Development, DS Process Sending unit,Operations, Engineering, Supply Chain, Quality, Quality Control,Regulatory and other involved departments to ensure successfulfacility startup and process qualification.

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​​PrincipalResponsibilities​

• ​​To provide processexpertisein one, or both of the following disciplines:

• ​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.

• ​To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents

• ​Toidentifyrequirements 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

• ​To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, materialspecificationsand outline testing requirements

• ​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

• ​Toidentifyand implement process improvements,e.g.yield, cycle time reduction

• ​To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale

• ​May berequiredto work periodically out of normal business hours (temporary shift working) during periods of engineering andvalidationbatch executionand provideon-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 andparticipatein risk assessments, audits, and incident investigations

• ​To author and reviewcommon technical document(CTD) sections and reportsfor regulatory agency submissions

• ​To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.

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​​Qualifications​

• ​​Minimum of 5 years’ experience in a pharmaceutical manufacturing organization, withexpertisein Bulk Drug Substance manufacturing, withpreviousexperience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer.

• ​Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operationsare cGMPcompliant.

• ​Engage in continual improvement through assessment and use of new PAT technologies.

• ​Good interpersonal skills coupled withdemonstratedability to effectively work in a matrix organization, and in local group settings.

• ​Ability to develop, build,presentand defend technical and scientific approaches in both written and verbalform.

• ​Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisionsbalancingproduct quality and operational requirements.

• ​Ability to aim forresults independently and adapt to rapidly changing priorities.

• ​ExperienceofTechnology Transfer activities isadvantageous.

• ​Knowledge or experience of start-up or systems would be ideal.

• ​Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to Alexion.

• ​Technical writing competency.

• ​Excellent organizational skills with strategic thinking and vision for the group.

• ​Demonstrated ability to aim forresults and lead innovation and change.

• ​Self-driven, able to prioritize, andto orchestratemultiple activities at once.

• ​Consistentlydemonstratesound business judgment when making

• ​decisions.

• ​Ability to deal with ambiguity and complexity and influence others across levels of the organization

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​​Education​

• ​​B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering

• ​M.Sc.or other postgraduate qualificationin Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.

• ​Experience of authoring CMC sections of regulatory submissions