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Details

Supervisor Biotech Production


Reference:POR245571 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Manufacturing Executive

A Supervisor Biotech Production - Upstream(Cell Culture) is required to join a rapidly expanding Biopharmaceutical organisation in Limerick. The focus of this role is to supervise the implementation of commercial manufacturing production schedules. You will supervise the manufacturing shift team in relation to process execution for Upstream and/or Downstream processes.

The Role

  • Supervises commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule.
  • Supervises a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
  • Ensures that the highest safety and housekeeping standards are maintained.
  • Supervises all aspects of respective areas of operations. Ensure there is effective process oversight at all times.
  • Reviews and edits batch records in accordance with cGMP standards.
  • Ensures availability of production batch records for upcoming lots.
  • Schedules shift duties and batch tasks based on master production schedule.
  • Ensures equipment readiness and coordinates regular equipment maintenance and calibrations; troubleshoots equipment.
  • Performs cGMP audits of production area.
  • Critical to the development of the leadership skills of their team leads.

The Person

  • Requires a 3rd Level Qualification in Life Sciences with 5+ years of relevant experience in manufacturing within the Biopharma industry.
  • Previous supervisory experience a distinct advantage.
  • Knowledge of cGMP and ICH guidelines.
  • Experience supervising shift organisations in the past would be a distinct advantage.
  • Strong knowledge of recombinant protein manufacturing techniques and methods, which include bioreactor culture and harvesting, liquid solution preparations, and purification and formulation of recombinant protein.
  • Excellent knowledge of Microsoft applications such as Excel, Word and PowerPoint. Excellent interpersonal, written, and oral communication skills.