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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Tech Transfer Lead - Sterile Drug Product


Reference:SMC03954 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Project Lead

We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


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.
  • 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.

Education & Experience Requirements:
  • 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.
  • 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.
  • 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.
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.