Senior Bioprocessing Expert

3 days ago

Shannon, Ireland beBeeBioprocessing Full time €75,000 - €102,000

Job Description:

We are seeking a seasoned professional to assume the role of Senior Bioprocessing Expert. This individual will serve as a Subject Matter Expert (SME) for a designated bioprocessing stage, ensuring technical, safety, quality, compliance, and continuous improvement.

  • Serve as SME for bioprocessing stages, driving process optimization and ensuring adherence to cGMP regulations.
  • Coordinate and supervise Bioprocessing Scientists during shifts, taking charge when required.
  • Develop and oversee training approaches for technical activities, guaranteeing high-quality execution.
  • Perform advanced manufacturing tasks in line with cGMP, leading rapid responses to quality issues and root cause analysis investigations.
  • Lead initiatives to address recurring deviations, enhance process yield, and improve quality and safety.

Requirements:

To be successful in this role, you will require:

  • A minimum of 5 years of hands-on experience in biopharmaceutical manufacturing, focusing on gene therapy, plasmid DNA, or viral vector production.
  • Comprehensive understanding of upstream and downstream bioprocessing operations, including fermentation, purification, and aseptic techniques.
  • Proven ability to handle quality events, including root cause analysis, CAPAs, change controls, and quality improvement initiatives.
  • Demonstrated experience in leading and mentoring teams, providing guidance, task allocation, and performance feedback.
  • A strong analytical mindset with the capability to troubleshoot process issues and implement effective solutions under GMP-compliant conditions.
  • Familiarity with GMP regulations and guidelines.
  • Ability to effectively collaborate with QA, QC, Technical Transfer, and other teams.
  • Strong written and verbal communication skills.
  • A proactive approach to driving process optimization and continuous improvement.

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