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Senior Specialist, Manufacturing Cell Banking| Meath

  • Sector: Science & Pharma
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 19226

Senior Specialist, Manufacturing Cell Banking| Meath

The Senior Specialist will be responsible for Cell banking activities including cell expansion, cell banking, Cell bank storage inventory management, assisting in troubleshooting cell banking problems and implementing process improvements.

Overview of Main Responsibilities (full job description available on request):

  • Support & Perform end-to end production activities of GMP Cell banks (Master and Working Cell Banks) and Release.
  • As an expert in operations, you will be a key point of contact for external groups to represent the operations team on projects / investigations / change management items as they arise.
  • Lead tech transfer related activities for cell bank manufacturing operations.
  • Act as end user where required for operations input into automation, equipment, process changes and to ensure that the operational aspects of any change are well understand and effective.
  • Mentor new members of staff in cell bank manufacturing specific activities.
  • Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization and continuous improvement projects.
  • Support Cell Bank Manufacturing area’s implementation of risk assessments, complex changes, and investigations.
  • Coordinate with cross-functional teams for IPC, Micro and Analytical testing activities
  • Liaise proactively with cross functional teams to identify opportunities for adoption of new technologies and approaches to achieve process or operational improvements.
  • Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
  • Work with Facility Management / internal team members in maintaining of the GMP status of responsible equipment and devices through routine monitoring, calibration, maintenance, and certifications.

What the ideal candidate looks like:

  • Bachelor’s degree or equivalent in biology, biotechnology, engineering, or related scientific discipline.
  • 5+ years of related experience in a biologics upstream manufacturing, Cell Culture Operations.
  • Familiarity with Unit Operations for manufacturing, experience in mammalian cell culture upstream operations.
  • Able to work independently and within a cross-functional team.
  • Experience working in a GMP environment.
  • Experience in biopharmaceutical manufacturing processes, equipment, and quality systems.
  • Experience with technology transfer, familiarity with contamination control and release requirements.

What you will get in return:

  • Competitive salary.
  • Bonus.
  • Pension.
  • Healthcare.

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675