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Senior QC Specialist, Limerick



Limerick, Ireland 

Job Category:

Biotech/Pharma, Science

EU work permit required:


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Job Description:

The Opportunity

Team Horizon is seeking a Senior QC Specialist to perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group.  Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. This is an opportunity to join our client’s select team that is already leading the way in the Pharmaceutical/Biotech industry.

The Role

  • Performs assay development/validation for QC Chemistry or Biochemistry groups
  • Reviews new test procedures and assays
  • Evaluates and bring in new methodologies/techniques when needed
  • Facilitate assay transfer from R&D and to business partners
  • Organize analytical assay transfer internally and externally
  • Lead technical troubleshooting and problem investigation
  • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
  • Participates in training programs for analysts
  • Represent QC in project teams and provide Quality input across functional areas
  • Oversee Contract Laboratory testing
  • Position requires strong technical skills in combination with strong communication skills in order to meet QC objectives
  • Requires approximately 30 to 40% of direct time in the laboratory
  • Write and review CMC sections for regulatory submissions

The Person

  • Requires Bachelor’s degree in Biochemistry, Chemistry, Biology or related field with 15+ years of relevant experience or advanced scientific degree such as a MS with 10+ years of relevant experience

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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