MSD Technology Transfer Delivery Lead Associate Director 

Ireland 

61040465

A new opportunity has arisen for
a Technology Transfer Delivery Lead (Associate Director)

Our facility in Dunboyne, Co. Meath is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Our Dunboyne site will provide Master/Working Cell Banking and Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.

Key responsibilities will include:

• Lead the overall RU coordination efforts to deploy Technology Transfer (TT) activities and process requirements for New Product Introduction (NPI), integrated with the Multiproduct platform.
• Hire and build team capabilities to meet the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification) TT activities. This team of specialists will be responsible for ownership and management of TT Master plans, PPQ protocols, PPQ reports and TT technical studies.
• Accountable for the delivery of process related TT activities, intended to meet the requirements of New Product Introduction (NPI) schedule, such as TT Change Control, PVL (Process Variable Limit) parameter build & parameter calculations, facility gap assessments, raw material identification.
• Consult on all operational readiness in cross-functional partnership with other key stakeholders, as required by each TT program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program.
• Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
• The team will be engaged in day-to-day TT delivery and execution and is a key stakeholder in strategic activities initiated to improve the TT end-to-end duration for future CTM (Clinical Trial Material) or commercial campaigns as they come through from early development.
• Provide site representation at program level working groups (WG) and as required at Development to Commercialization Teams (DCT), engaging cross functionally with stakeholders to deliver site-based activities of the relevant program.
• Work in partnership with DS Process Operations, DS Support Operations and Technology and Engineering teams to manage non-platform risks with consideration for 'Lights-out' operating model and a working rhythm that allows for agility and movement of staff.
• Embody an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally, collaborating across the network on sharing best practices and lessons learned.
• Embedding a culture that aligns with the Ways of Working at the site and is committed to both the facility and site priorities.

The successful applicant will have the following education, skills, and experience:

• Appropriate qualification in science or engineering
• Minimum of 8 years of experience in GMP-regulated biological drug substance and/or cell banking manufacturing environment in any/all the following: Clinical Supply, Registration & Commercial Launch.
• Proven experience in People Leadership role(s) with capacity to leverage deep technical knowledge/experience which will support TT and NPI delivery for biologics products.
• Relevant knowledge and experience in single-use systems, SAP, Delta V and MES (Manufacturing Execution System) an advantage.
• Excellent problem-solving, troubleshooting, and analytical skills.
• Effective communication, collaboration, and influencing skills across all levels and functions.

So, if you are ready to: