Technical Services Specialist
A Technical Services Specialist is required to provide processing expertise to support the technology transfer, process validation, and routine commercial manufacturing for Upstream and Downstream manufacturing in a biopharmaceutical company based in West Dublin.
Key Responsibilities:
* Provide process support in one or both of the following disciplines: upstream (media preparation, large scale cell culture bulk drug substance manufacturing processes) and downstream (buffer preparation, purification, and viral reduction).
* Develop, review, and approve process, buffer, and media electronic batch records (EBR).
* Author and review process transfer documentation, gap assessments, technical protocols, reports, and process validation documentation, strategy documents.
* Identify requirements for laboratory studies to support process fit, decisions, or process transfer and liaise closely with Global Process Development and Contract Manufacturing Organisation (CMO) to oversee the design and execution of studies.
* Support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications, and outline testing requirements.
* 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.
* Identify and implement process improvements, e.g., yield, cycle time reduction.
* 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.
* Provide on-the-floor support for troubleshooting processing issues and lead manufacturing investigations into process deviations and resolution.
* Lead any key process changes using change control system.
Requirements:
* 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.