Technical Services Specialist

12 hours ago

Dublin, Ireland Tandem Project Management Limited Full time

Summary: A Technical Services Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will provide will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and Downstream manufacturing. The incumbent will be responsible for development, review and or approval of process, buffer and media electronic batch records (EBR), providing support for technology transfer of new and existing drug substance (DS) manufacturing processes to site, and will be required to work in close collaboration with other departments and Contract Manufacturing Organisation (CMO). Responsibilities: Provide process support in one, or both of the following disciplines: upstream (media preparation, large scale cell culture bulk drug substance manufacturing process...) and downstream (buffer preparation, purification and viral reduction). To develop, review and or approve process, buffer and media electronic batch records (EBR). 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 and CMOs 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, M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. Minimum 3+ years experience in Technical Services / Process Development / Experience of authoring CMC sections of regulatory submissions. Experience with EBR (electronic batch records). Manufacturing Support in a biological bulk drug substance manufacturing organization. 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 advantageous. Technical writing competency. Skills: Technical Services Process Development EBR cGMP Technical writing

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