Technical Transfer Scientist

4 weeks ago

Sligo, Sligo, Ireland Cpl Full time
JO-2507-554629

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 01 614 6178 / 087 180 4358 or [email protected]

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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