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Cell Culture Processing Expert

1 week ago

Dublin, Dublin City, Ireland PE Global (UK) Full time
Responsibilities

The successful candidate will be accountable for timely completion of commercial sustaining and technical transfer related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Continued Process Verification (CPV), Risk Assessment (using QRM tools), and supporting technical and manufacturing deviations.

  • To provide process expertise in Downstream purification process: buffer preparation, purification, and viral reduction steps including chromatography, ultrafiltration viral reduction filtration, and viral inactivation technologies.
  • To author and review process technical documentation, gap assessments, technical protocols, reports, and process validation documentation.
  • To lead or support the continuous process verification program at ADMF.