Technology Transfer Specialist, Sterile Drug Product We’re currently recruiting for an exciting opportunity with a leading global biopharmaceutical organisation based in Dún Laoghaire.
This position will support new product introductions and lifecycle management activities within commercial biologics drug product manufacturing. The successful candidate will take responsibility for technology transfer activities from initial process definition through line characterisation, engineering studies, PPQ and regulatory approval.

Duties

• Support and lead new product introductions from a Process Development perspective, from initial concept through PPQ and product filing.
• Take accountability for technology transfer projects through line characterisation, engineering studies, process validation and regulatory approval.
• Develop documentation for characterisation studies, engineering runs, validation plans and process performance qualification.
• Support the creation and implementation of electronic batch records for syringe filling processes.
• Troubleshoot protein freeze-thawing, formulation, filtration, mixing, syringe filling, inspection and transportation processes.
• Provide technical support to commercial biologics drug product manufacturing operations.
• Support sterile processing, process characterisation, technology transfer and process validation activities.
• Review and approve process validation protocols, assessments and technical reports.
• Evaluate change controls, non-conformances, deviations and CAPAs from a process development perspective.
• Lead or participate in cross-functional teams involving manufacturing, quality, regulatory, engineering and global process development.
• Act as the receiving-site point of contact for drug product transfer teams and global operations groups.
• Support filter validation, shipping validation and product quality assessments.
• Contribute technical input to new facility, equipment and process design activities.
• Support root cause analysis and the resolution of process deviations and exceptions.

• Bachelor’s degree in science, engineering or a related discipline with at least four years of relevant experience, or an equivalent combination of education and directly related industry experience.
• Experience within commercial biologics drug product manufacturing, NPI, MSAT, Process Development or Technical Services.
• Strong understanding of sterile processing, process characterisation, technology transfer and process validation.
• Experience with prefilled syringe or syringe filling processes is highly desirable.
• Knowledge of protein freeze-thawing, filtration, formulation, mixing and batch homogeneity.
• Experience developing or executing engineering studies and PPQ protocols.
• Strong knowledge of cGMP, quality systems and international regulatory requirements.
• Experience supporting change controls, deviations, investigations and CAPAs.
• Excellent technical writing, communication and stakeholder-management skills.
• Demonstrated ability to lead cross-functional technical projects through to completion.