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17921050 Scientist II

Manufacturing / Production
Dublin
Sharmini Yapan
Temporary
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Job Reference: JO-2212-66353_1673518112

Summary:

Scientist II

(12-month contract)

The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by a global biopharmaceutical company to produce commercial and clinical product. This position provides strong scientific leadership for all aspects of technology transfer, validation, process scale-up, inspection, process monitoring, and process troubleshooting for manufacturing activities.

The role requires strong expertise in operational excellence and 6-sigma methodologies. The successful candidate will use their operational excellence expertise to identify, analyze and prioritize optimization opportunities at CMOs, and drive the necessary projects to deliver on yield commitments.

Responsibilities:

  • Providing technical and scientific direction for technology transfer and validation of Drug Product at CMOs.
  • Lead troubleshooting and root cause analysis activities using best in class problem solving for critical issues at Drug Product CMOs
  • Use lean six-sigma expertise to identify, analyze amd prioritize optimization and yield improvement opportunities across Drug Substance, Drug product and Final Packaging CMOs.
  • Involvement in cell bank governance.
  • Up to 20% international travel may be required.

Requirements:

  • Minimum of 5 years' experience in a technical or manufacturing role in the pharmaceutical industry.
  • High level of technical expertise in pharmaceutical manufacturing across multiple technology and processing areas.
  • Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
  • Expertise in operational excellence, lean six-sigma and Project Management.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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