Process Development Scientist

3 days ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €90,000 - €120,000

The role of Process Development Scientist will be pivotal in driving commercial manufacturing and technology transfer within our drug substance production facility.

Responsibilities:
  • Support the delivery of commercial manufacturing to meet business requirements, encompassing investigations, process robustness, and improvements.
  • Scale up mammalian cell culture processes from laboratory and pilot scale to a large-scale manufacturing facility.
  • Execute feasibility studies, mass balance generation, equipment sizing, gap assessments, and mitigation strategies to ensure seamless process transfer.
  • Provide independent strategic input into facility and equipment design.
  • Develop, review, and execute technology transfer protocols, supporting documentation, experimental design, and scaled process trials for efficient technology transfer.
Requirements:
  • A minimum of 3-6 years of experience in mammalian cell culture process development, late-stage characterisation, technical transfer, and technical services in stainless steel and/or single-use facilities.
  • Demonstrated expertise and in-depth knowledge of cell culture scale-up practices, technical transfer, facility fit, equipment sizing, and mass balance generation for clinical/commercial manufacture.
  • Familiarity with process validation strategies, studies, and regulatory requirements.
  • Knowledge of regulatory submissions and responses to queries from health authorities.
  • In-depth understanding of cGMP regulatory requirements related to the design and control of drug substance processes.

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