Leading Process Specialist

2 weeks ago

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

Process Development Scientist

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We are seeking a highly skilled Process Development Scientist to support commercial manufacturing and technology transfers. As a key member of the technical services team, you will play a critical role in delivering efficient technology transfers.

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Key Responsibilities:

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  • Support commercial manufacturing to meet commercial requirements, including investigations, process robustness, and process improvements.\
  • Scale up mammalian cell culture processes from bench and pilot scale to a large-scale manufacturing facility.\
  • Perform, present, and execute facility fits, mass balance generation, equipment sizing, gap assessments, and mitigation of operational challenges to ensure an equivalent process is transferred.\
  • Provide independent decision making for strategic input into facility and equipment design.\
  • Prepare, review & execute technology transfer protocols, supporting documentation, design of experiments, and at-scale process trials to deliver efficient technology transfers.\
  • Author and review responsible sections of regulatory dossiers, including health authority query responses.\
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Requirements:

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  • Minimum of 3-6 years of mammalian cell culture process development/late-stage characterisation and technical transfer/technical services experience in stainless steel and/or single use facilities.\
  • Demonstrated history and in-depth knowledge of cell culture scale-up practices, technical transfer, facility fit, equipment sizing, and mass balance generation for clinical/commercial manufacture.\
  • Knowledge and experience of process validation strategies, studies, and requirements.\
  • In-depth knowledge of cGMP regulatory requirements related to the design and control of drug substance processes.\
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Skills:

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  • High technical capability, interpret complex data, problem-solving, and technical learning.\
  • Promote information sharing and excellent interpersonal skills.\
  • Capability of working in a multi-disciplinary team environment to tight timelines.\
  • Effective communication, planning, and organisation skills to deliver documentation.\

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