Technology Transfer Delivery Lead

5 days ago

Rahway, United States MSD Malaysia Full time
Technology Transfer Delivery Lead (Associate Director)

Apply remote type Hybrid locations IRL - Meath - Dunboyne time type Full time posted on Posted 3 Days Ago time left to apply End Date: January 6, 2025 (16 days left to apply) job requisition id R327726

A new opportunity has arisen for a Technology Transfer Delivery Lead (Associate Director) to join the team at our newly constructed state Biologics Innovation facility located at Dunboyne, County Meath, Ireland.

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.

The Technology Transfer Delivery Lead will be a member of the site Manufacturing Operations Leadership team, reporting to the Head of Manufacturing. The successful candidate will:

  • Be a key stakeholder in the execution of the multiproduct strategy for Technology Transfer and New Product Introduction (NPI).
  • Oversee the execution of the RU (Receiving Unit) TT process related activities from siting to batch execution inclusive of Cell Banking and DS Manufacturing and oversee the execution of SU (Sending Unit) TT activities as required.

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.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

  • Invent solutions to meet unmet healthcare needs,
  • Impact the future by driving one of the world’s leading healthcare companies, and
  • Inspire your team to reach their full potential and push the boundaries of science and technology,

please apply today.

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