MSD Drug Substance Process Operations Business Excellence Snr Specialist 

Ireland 

216767980

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Accountable for end-to end production supporting (Cell Expansion, Upstream, Downstream, Solution Supply) for both Batch and Continuous Manufacturing. A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
• You will be responsible for creating and maintaining project plans, defining project scope, objectives, deliverables, and timelines. This includes establishing project goals and objectives, identifying project tasks and dependencies, and developing a project schedule for projects within the Drug Substance Process Operations team.
• Collaborating with cross-functional teams to develop production plans based on demand forecasts, capacity, and resource availability.
• Providing regular project updates to management and stakeholders, including progress, challenges, and recommendations.
• Providing guidance, motivation, and support to project team members.
• Collaborating with production managers and other stakeholders to understand production requirements, capacity constraints, and priorities.
• Identifying opportunities for process improvement and implementing strategies to streamline scheduling processes.
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
• Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.
• Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation).
• Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs/WI’s.
• Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.

What skills you will need:

• Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
• 6 years + experience in Biotech industry (bulk manufacturing of pharmaceutical or biological components).  Position level will scale with experience level of candidate.
• Competent in analyzing complex situations and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Demonstrated experience in QRM, Investigations and Problem solving
• Familiarity with contamination control and batch release requirement
• Experience in quality management systems such as Veeva, SAP, PAS-X etc..
• Experience in Quality Assurance, Quality Control within the Biological and/or pharmaceutical industry.

Preferred Experience and Skills:

• Commissioning and Qualification experience
• Problem, Deviation, and Change Management experience
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
• Familiarity with Emerson DeltaV, SIPAT,  and the use of Automation in a manufacturing Process.
• Familiarity with contamination control and batch release requirements
• Experience in facilitating internal audits and regulatory inspectionswith regulatory agencies during site inspection
• Experience in the area of project management

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today

Current Contingent Workers apply

Hazardous Material(s):

Job Posting End Date:07/05/2024

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