MSD Associate Director - Drug Substance Process Operations 

Ireland 

772015545

Job Description

A new opportunity has arisen for aDrug Substance Process Operations, Associate Director(DPSO AD)

The Associate Director of Drug Substance Process has a variety of key responsibilities.

• Leading a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical or Commercial campaigns.
• Overseeing the coordination efforts for Drug Substance Manufacturing Execution (DS Process Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.
• Management of the Operations team, which includes hiring and building team capabilities to meet the operational requirements of the facility.
• Embedding a culture that aligns with the Ways of Working and is committed to both the facility and site priorities.
• Overseeing production planning and associated activities, integrated with the facility Multiproduct platform.
• Championing the implementation of the lights-out manufacturing philosophy. Establishing a working rhythm that allows for agility and movement of staff between Cell Expansion, Process Platforms for Fed Batch and Continuous Manufacturing, and Solution Supply. This includes designing a flexible skill matrix for training aligned with the working rhythm.
• Ensuring operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer 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).
• Accountable for the management of the Production Alarm System, Sample Management Processes (GLIMS), Change approver for MES, Delta V Recipes, and material BOMs, Manufacturing approver of process descriptions.
• Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network partners for a common approach.
• Supporting the deployment of phase-appropriate Quality Management Systems (QMS) within the facility, including Change and Deviation Management.
• Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
• Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.

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

• Degree level qualification in science or engineering.
• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Proven experience in a leadership role with technical transfer experience in the biotech sector in any/all the following: Clinical Supply, Registration & Commercial Launch.
• Possess a deep understanding of amanufacturing/operationalGMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.
• Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today.

Current Contingent Workers apply

Not Applicable