Biotechnology Transfer Professional

7 days ago

Sligo, Sligo, Ireland beBeeTransfer Full time €60,000 - €80,000

Job Title: Technical Transfer Specialist

We are seeking a skilled Technical Transfer Scientist to join our team at our biotech site in Sligo town.

The successful candidate will have experience in NPI and production support in the biotechnology and/or pharmaceutical sector. They will also be responsible for authoring, reviewing, and executing process validation reports.

Key Responsibilities:

  • Plan and coordinate technical transfer activities to ensure the successful transfer of processes and technology.
  • Focus on assigned technical transfer activities for new products and filling and inspection processes being transferred into the site.
  • Use a risk-based approach to technical transfer activities for planning, readiness, and execution.
  • Develop functional partnerships with site business units to address technical transfer activity-related issues.
  • Provide on-the-floor process support with enhanced support during engineering runs.
  • Introduce/establish statistically based tracking metrics.
  • Raise, investigate, and close out non-conformances, planned deviations, and change control requests.
  • Perform sample analysis in accordance with standard operating procedures (SOPs) where required.
  • Coordinate the use of external test laboratories when required.
  • Present issues relating to technical transfer and routine process monitoring activities to cross-functional teams.

Requirements:

  • A minimum of a Master's degree in a technical discipline (e.g., biochemistry, chemistry, biotechnology, biopharmaceuticals). A PhD is desirable.
  • Experience in the biotechnology and/or pharmaceutical industry, with operational experience of new product introductions and product support essential.
  • Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals, and/or biologicals.
  • Experience in authoring, reviewing, and executing process validation studies and reports is a must.
  • Experience with vaccines would be preferable, particularly in the area of product development and stewardship.
  • Experience in cleaning validation is desirable.

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