Job Title: Technical Transfer Scientist
We are seeking a highly skilled Technical Transfer Scientist to join our team. As a key member of our organization, you will play a critical role in expanding our biotech site in Sligo town.
The successful candidate will have significant experience in NPI and production support in the biotechnology and/or pharmaceutical sector. Experience in authoring, reviewing, and executing process validation reports is essential.
You will be responsible for planning and coordinating Technical Transfer activities to ensure a successful transfer of processes and technology. This will involve a risk-based approach to Technical Transfer activities for planning, readiness, and execution.
You will develop functional partnerships with business units to address Technical Transfer activity-related issues. On-site process support, including enhanced support during Engineering runs, is also a key aspect of this role.
You will introduce statistically based tracking metrics, raise, investigate, and close out non-conformances, planned deviations, and change control requests as needed. Sample analysis according to standard operating procedures (SOPs) and coordination of external test laboratories will also be part of your responsibilities.
You will present issues related to Technical Transfer and routine process monitoring activities to cross-functional teams and help develop business cases for courses of action as appropriate.
Key Requirements:
* A minimum of a Master's degree in a technical discipline, such as biochemistry, chemistry, biotechnology, or 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 manufacturing processes and equipment necessary for pharmaceuticals, parenterals, and/or biologicals.
* Experience in authoring, reviewing, and executing process validation studies and reports is mandatory.
* Experience with vaccines, particularly in product development and stewardship, is preferable.
This is an exciting opportunity to join our dynamic team and contribute to the growth and success of our organization.