Biotech Expertise

1 week ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €6,000 - €7,500
Job Opportunity

This is an exciting chance to work as a Senior Tech Transfer Specialist. The successful candidate will provide process development support primarily to new product introductions and lifecycle management changes.

The individual will also provide technical support to biologics drug product manufacturing as part of the global Process Development organization.

Key Responsibilities:
  • 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.
  • Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams.
  • Collate and report on relevant shipping and filter validation.
Requirements:
  • A 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.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem solving ability and excellent oral and written communications skills.
Preferred Qualifications:
  • Doctorate or Masters in Science or Engineering.
  • 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.

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