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Senior Biotechnology Product Developer

2 weeks ago

Dublin, Dublin City, Ireland beBeeProcess Full time €45,000 - €55,000
Biotech Process Development Specialist

This is an exciting opportunity to support the development of new biotechnology products. Our client, a leading international company, is currently undergoing rapid expansion and capital investment in its Irish plant.

The successful candidate will provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. In addition, they will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization.

Key Responsibilities:

  • Supports new product introductions from a Process Development perspective and then serves 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 knowledge 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.

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.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem solving ability and excellent oral and written communications skills.

Packages:

  • Contract role - Hourly rate €45 - €55 per hour / €67.50 shift rate when required.
  • Minimum 12 month contract with the strong possibility of an extension.

Work Schedule: Predominantly normal working hours, with a 35% shift commitment. Be prepared for occasional shift work due to upcoming NPIs and LCMs.