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Details

Technical Support Specialist - Drug Substance


Reference:SMC8274 Location: Louth
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Technical Specialist

We’re currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities:

  • Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream.
  • Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
  • Coordinate technical deliverables within Drug Substance to support the successful product launch.
  • Provide technical support to the operations team’s during commercial manufacturing.
  • Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
  • Support Batch Disposition activities by providing SME technical support for comment resolution.
  • Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.
  • Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
  • Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
  • In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization.
Education & Experience Requirements:
  • Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
  • Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
  • Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
  • Experience in a risk-based approach to manufacturing through use of tools such as FMEA

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.