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QC Bioanalytical Manager

I am working for a leading Biotechnology company who are actively seeking a Bioanalytical Manager for their newly established facility in Limerick

This company are building the largest biotechnology manufacturing facility in Ireland at a rapid pace. The company has a strong culture of innovation and R&D.

The Bioanalytical Manager will oversee the laboratory quality control testing of in-process, stability, and final drug products. You will also technical responsibility for all bioanalytical aspects of QC testing.

Responsibilities:

Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.

  • Oversees product testing to ensure efficient and compliant operations.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
  • Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation and timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement event.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations

Education and Experience:

  • BS in chemistry, biology or related field with 8+ years' relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years' experience in a supervisory/leadership capacity.
  • Thorough understanding of bioanalytical techniques in a cGMP environment.

For immediate consideration please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information.

To find out more about Real please visit www.realstaffing.com

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