Summary:
An Upstream Technical Services Specialist is required for a biopharmaceutical company in West Dublin. The incumbent will have primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS). The successful candidate will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for downstream manufacturing.
Responsibilities: Upstream activities (cell culture focus) that 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. 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. 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 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 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 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. To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections. Qualifications & Experience: B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. Minimum 2+ years' experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization. Experience of authoring CMC sections of regulatory submissions. Technical and operational knowledge of multiple unit operations in cell culture processing. Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing. Experience of Technology Transfer activities is highly advantageous.
Technical writing competency.
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