This role is a 12 Month Contract with a View to extension.
The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at The facility in Dublin. The Technical Specialist will provide processing expertise to support routine commercial manufacturing, technology transfer, and process validation for Upstream manufacturing of new/existing drug substance (DS) manufacturing processes to the Dublin facility. The person will be required to work in close collaboration with Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory, and other involved departments to provide successful process support. The person should have experience in cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.
• To provide process expertise in Upstream unit operations 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 documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
• To identify requirements for laboratory studies to support process decisions or process transfer, and to liaise closely with Process Development / MSAT 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, material specifications, and outline testing requirements.
• To work closely with colleagues in Quality, Supply Chain, and Manufacturing Operations to ensure the availability and release of materials to meet technology transfer and routine manufacturing timelines.
• To identify and 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 a 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.
• 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 a change control system.
• Adherence to the highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
• To author and review common technical document (CTD) sections and reports for regulatory agency submissions.
• To serve as a subject-matter expert (SME) on Upstream unit operations and process support during regulatory agency inspections.
• Minimum 2+ years of experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization.
• Technical and operational knowledge of multiple unit operations in upstream processing.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and local group settings.
• Ability to present and defend technical and scientific approaches in both written and verbal form.
• Ability to drive for results independently and adapt to rapidly changing priorities.
• Experience in Technology Transfer.
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