Biotech Manufacturing Team Lead Position

5 days ago

Sligo, Sligo, Ireland beBeeTechnicalTransferLead Full time €75,000 - €93,000
Key Responsibilities:
  • Lead technical expertise and provide technical leadership for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls.
  • Provide team leadership - setting work goals, controlling and meeting goals, professional and personal development of team members.
  • High level of on-the-floor activity to support production issues.
  • Lead product-related problem-solving initiatives – be inquisitive.
  • Understand science of process incl process flows, CPP's, historical failures.
  • Conduct process monitoring/trending.
  • Support QA with generation and closure of annual product reviews.
  • Use Continuous Improvement tools for incremental change.
  • Implementation of new production methods, Technology transfer: Examination of production methods prior to their transfer to production, including validation (when needed).
  • Follow-up and training of production teams.

For success in this role, you will need a strong background in the biotechnology and/or pharmaceutical industry, particularly in new product introductions and product support. You should have knowledge of processes and equipment necessary for manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals. Additionally, experience in authoring, review and execution of validation studies and reports is essential. Experience with vaccines would be preferable, particularly in the area of product development and stewardship. Your ability to prioritize workload for self and reports, as well as coaching and mentoring a team, will be crucial. A demonstrated ability in leading root cause analysis and effective investigation practices is also required.

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