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Technical Scientist required for expanding biotech site in Sligo town. The successful candidate will have experience in the biotechnology and/or pharmaceutical sector with Operations experience of new product introductions and product support.
Get in touch with me for further information : Deirdre Murphy on 01 / or
Role
1. Plan and coordinate the assigned Technical Transfer activities to ensure a successful transfer of processes and technology.
This will include:
•Developing instructions relating to production operations (tableting/packaging)
•Review and report on data relating to Technical Transfer activities
•Working with the scheduling team to schedule Technical Transfer activities
•Support the Manufacturing team throughout the manufacturing process
•Developing protocols as required
ªFocus on assigned Technical Transfer (TT) activities for new products and filling and inspection processes being transferred into the site.
ªUse a risk-based approach to TT activities for planning, readiness & execution.
ªDevelop functional partnerships with the required site business units to address TT activity related issues.
ªContinuously support the manufacturing processes through:
•Provide on the floor process support with enhanced support during Engineering runs
•Introduce/Establish statistically based tracking metrics
•Continuously monitor process CPP's and update the process databases
•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 TT and routine process monitoring activities to cross functional teams and help develop and deliver business cases for courses of action as appropriate
Requirements
2. A minimum of a Masters degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals). A PhD. is desirable.
3. Experience in the biotechnology and/or pharmaceutical industry, with Operational experience of new product introductions and product support.
4. Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
5. Experience in authoring, review and execution of process validation studies and reports is a must.
6. Experience with vaccines would be preferable particularly in the area of product development and stewardship.
7. Experience in cleaning validation is desirable.