Technical Transfer Scientist

2 weeks ago

Galway, Galway, Ireland Cpl Healthcare Full time

JO

Technical Transfer Scientist required for expanding biotech site in Sligo town. The successful candidate will have NPI and production support experience in the biotechnology and/or pharmaceutical sector. Experience in authoring, review and execution of process validation report is required.

Get in touch with me for further information: Deirdre Murphy on /

Please note - applicants need to have a Stamp 4 or to have unrestricted full working rights for Ireland

Role

  • Plan and coordinate the assigned Technical Transfer activities to ensure a 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 & execution.
  • Develop functional partnerships with the required 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
  • Where required performs sample analysis in accordance with standard operating procedures (SOPs)
  • Coordinates the use of external test laboratories when required
  • Present issues relating to Technical Transfer and routine process monitoring activities to cross functional teams and help develop and deliver business cases for courses of action as appropriate

Requirements

  • A minimum of a Masters 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, review and execution of 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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