Website TPM05546
Summary:
A Technical Transfer Lead is required for a biopharmaceutical company in South Dublin. The successful candidate will provide process development support primarily to new product introductions and lifecycle management changes. The incumbent will lead process performance qualification.
Responsibilities:
- Leads new product introductions from a process development perspective and then will serve as the Process Development SME for these products following completion of the transfer.
- 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.
- 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 the 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.
- Moderate international travel might be required during the course of the project.
Qualifications & Experience:
- Third level Bachelor’s degree in science, engineering or a relevant quality discipline.
- 5 + years of experience in support of commercial protein drug product 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 skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (process performance / batch homogeneity) 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.
- Strong knowledge of quality systems, drug product manufacturing and validation.
To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.