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Contact Info
Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Manufacturing Technical Operations Manager


Reference:POR606768 Location: Limerick
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

A Manager Manufacturing Technical Operations – Upstream or Downstream is required to join a rapidly growing Biopharmaceutical organisation in Limerick. Reporting into the Manufacturing Director, this role is a key member of the operations management team. The focus of this position is to Provide technical management and support to ensure key deliverables of the manufacturing department are achieved.

The Role

  • Ensures large scale commercial and clinical batch processing continuously meets SISPQ requirements.
  • Ensures compliance deviations are managed and closed in a timely manner to continuously meet lot disposition timelines.
  • Performs area manager function for complex investigations, ensuring robust investigations are performed while meeting disposition timelines. Leading investigations where it is deemed necessary.
  • Assesses, approves and oversees implementation of process related change control.
  • Provides technical direction to resolve immediate process issues.
  • Participates in continuous process monitoring to identify areas of focus for continuous improvement and process robustness.
  • Develops programs and strategies to ensure continuous improvement and continued robustness of the large scale and clinical processes.
  • Key member of the manufacturing team in support of regulatory audits.
  • Leads and implements continuous improvement initiatives.


The Person

  • Bachelor, Master, or Doctorate degree in any of the physical or biological sciences, or chemical engineering and 10 -12 years biopharmaceutical/biotech work in a GMP production facility with BA/BS, alternatively 8 to 10 years with MA/MS, or 4-7 with PhD. 8+ years people management experience required;
  • Strong knowledge of recombinant protein manufacturing techniques and methods, which include purification and formulation of recombinant proteins;
  • Excellent interpersonal, written, and oral communication skills;
  • Substantial knowledge of cGMP’s and experience in engaging with regulatory authorities.
  • Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff.