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Details

Manufacturing Operations Manager


Reference:POR056606 Location: Limerick
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

A Manufacturing Operations Manager is required to join a leading Biopharmaceutical business in Limerick. The Manufacturing Operations Manager is a key member of the downstream operations management team that manages and directs all facets of downstream commercial and clinical scale production at the site. Reports to Downstream AD/ DIR.

The Role

  • Manages downstream commercial & clinical scale manufacturing according to approved protocols, regulation, and schedule.
  • Provides technical input to resolve process problems and complex compliance issues.
  • Communicate with Supervisors/Managers regarding technical, compliance & production process related issues
  • Implements new production processes transferred by the MSAT/PMPD teams
  • Performs cGMP audits of production area.
  • Represents manufacturing during regulatory audits.
  • Ensures that safety standards are maintained. Supports departmental safety projects.
  • Performs personnel management functions including scheduling of holidays, personnel development, and performance evaluations.

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
  • 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.
  • Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment
  • Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff.