JO-2507-554629
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 01 614 6178 / 087 180 4358 or [email protected]
Role
- 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
ª Focus on assigned Technical Transfer (TT) activities for new products and filling and inspection processes being transferred into the site.
ª Use a risk-based approach to TT activities for planning, readiness & execution.
ª Develop functional partnerships with the required site business units to address TT activity related issues.
ª Continuously 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
- 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.
- 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.
