LSC have a great contract opportunity for a Tech Transfer Lead ( Senior) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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.
- 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.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Third level Bachelor's degree in science, engineering or a relevant quality discipline with 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.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam Murphy on 021 4777329 if you have anymore questions about this role!
