Job Title: Technical Services Specialist
Location: West Dublin
A Technical Services Specialist is required to provide processing expertise in support of technology transfer, process validation, and routine commercial manufacturing for Upstream and Downstream manufacturing.
The successful candidate will be responsible for the development, review, and approval of process, buffer, and media electronic batch records (EBR), providing support for the technology transfer of new and existing drug substance (DS) manufacturing processes to site. This role will also involve close collaboration with other departments and Contract Manufacturing Organisation (CMO).
Key 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).
* Develop, review, and approve process, buffer, and media electronic batch records (EBR).
* Author and review process transfer documentation, gap assessments, technical protocols and 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 CMOs 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.
* Adhere 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.
* Author and review common technical document (CTD) sections and reports for regulatory agency submissions.
* 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).
* Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
* Experience of Technology Transfer activities is advantageous.
* Technical writing competency.