Job Summary
We are seeking an experienced professional to join our Biopharmaceutical organization in Dunboyne. This is a fantastic opportunity to work with a leading multinational that excels in its industry.
Duties and Responsibilities
* Participate in and lead key technology transfers activities, supporting clinical and commercial new product introduction projects.
* Develop strategies for and support the execution of technology transfer, process, and clean validation programs in line with company, industry, and regulatory standards.
* Act as a process Subject Matter Expert, supporting process investigations.
* Apply risk management techniques to assess strategies, prioritize activities, and initiatives.
* Lead significant business-critical projects associated with new product introduction and site capability build.
* Act as system owner and Subject Matter Expert (SME) to support investigations, using risk management techniques to prioritize activities and initiatives.
* Ongoing optimization of process equipment and development of future breakthrough business solutions.
Requirements
* Experience in biologics drug substance environment.
* Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
* Experience in technology transfers for clinical or commercial biologics strongly desired.
* Experience with automated systems highly desired.
* Process validation and cleaning validation experience desired.