Technical Transfer Scientist
- Sligo
- Permanent
- Full-time
- 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
- 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.