Job Title: Biopharmaceutical Tech Transfer Specialist
We are seeking a highly skilled and experienced Biopharmaceutical Tech Transfer Specialist to join our team. This is an exciting opportunity to work with a leading multinational biopharmaceutical organization based in Dunboyne.
About the Role:
* Collaborate with stakeholders to execute transfer requirements for late stage clinical and/or PPQ programs.
* Attend meetings with local and international groups to coordinate implementation tasks for new Drug Substance processes.
* Manage program introduction schedule to ensure timely and right-first-time execution of tasks.
* Deliver GMP documents related to TT, including Risk assessments, change controls, batch records, sampling plans, and Bills of Material.
* Support development of process descriptions, process models, facility fits, and other TT-related documents for continuous and fed-batch processes.
* Employ innovative mindset to identify and implement opportunities for product launch.
* Maintain highest Quality, Compliance, and Safety standards, adhering to Safe by Choice guidelines and contributing to company safety and environmental goals.
* Solve problems, take new perspectives, and continuously learn, improve, and develop.
* Demonstrate excellent troubleshooting and problem-solving skills, as well as influencing, collaboration, and teamworking abilities to work with global and interdisciplinary teams.
Requirements:
* Minimum 3 years of experience in pharmaceutical or biotech industry.
* Bachelor's degree in Engineering, Biotechnology, Chemistry, or related field.
* Technical knowledge of Biologics drug substance upstream and downstream operations or process development.
* Understanding of New Product Introduction NPI/Tech Transfer principles and activities.
* Familiarity with Automation systems (e.g., DeltaV, MES, eVal) and business tools (e.g., Power Project, Power BI).
* Experience in GMP-regulated biological drug substance manufacturing environment, preferably with single-use systems.
About Us:
We are a leading multinational biopharmaceutical organization committed to delivering innovative products and solutions that improve human health. Our team is passionate about making a difference and working together to achieve excellence.