Tech Transfer Lead

About the Role

Join a globally renowned pharmaceutical organization in Dublin spearheading advancements in biologics manufacturing. As the Tech Transfer Lead, you will play a crucial role in facilitating the seamless transition of biologics drug substance processes from development to full-scale manufacturing.

Key Responsibilities

• Oversee the entire lifecycle of technology transfer projects, covering biologics drug substance processes, encompassing both upstream and downstream operations.
• Formulate and implement technology transfer strategies, including detailed planning, scheduling, risk management, and ensuring manufacturing readiness.
• Collaborate with process development groups to ensure comprehensive transfer of key process knowledge such as critical process parameters (CPPs), control strategies, and material characteristics.
• Direct cross-functional project teams, proactively manage and mitigate risks, ensure all stakeholders are aligned, and resolve issues to guarantee successful transfers.

Candidate Requirements

• Significant background in process development, MSAT, tech transfer, or manufacturing, with comprehensive experience in both upstream and downstream biologics processes.
• In-depth knowledge of cGMP standards, incorporating process validation, quality management systems, and regulatory compliance relating to biologics manufacturing.
• Demonstrated experience in leading diverse technical teams and successfully managing complex, multi-site projects to completion.
• Outstanding communication and stakeholder management abilities, essential for effective coordination with internal teams and external partners.