A Tech. Transfer Lead is required for a biopharmaceutical company in South Dublin. This The successful candidate will provide process development support to new product introductions (NPI) and lifecycle management (LCM) changes on site. The incumbent will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ).
- Leads new product introductions on site from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to site.
- Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
- Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.
- Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.
- Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
- The position will report to Process Development Senior Engineer.
- Moderate international travel might be required during the course of the project.
- Development of validation plans, process performance qualifications for vial and syringe filling.
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
- Act as the responsible point contact from our client site for the transfer project for drug product teams and Global Operations Teams.
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
- Collate and report on relevant shipping and filter validation.
- Assist in deviation and exception resolution and root cause analysis.
- Contribute to product quality assessments and process flow documents.
Qualifications & Experience:
- Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience.
- Doctorate or Masters in Science or Engineering preferred.
- 10+ years experience Tech Transfer in a similar role, (ie in a lead role, decision maker).
- Product development, process/product design, develops and characterizes drug product processes experience.
- 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes.
- Knowledge of protein biochemistry with regard to chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
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