Our client is a bio pharmaceutical company based in West Dublin, looking for a Technical Services Specialist who will be responsible for supporting the cGMP manufacture of biological bulk drug substance. 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.
- 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, and 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 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 Upstream unit operations 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 is desirable.
- Experience of authoring CMC sections of regulatory submissions.
- Minimum 2+ years’ 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.
- Ability to present and defend technical and scientific approaches in both written.
- Experience of Technology Transfer and statistical analysis is advantageous.
Technical writing competency.
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