Summary
A CMO Operations Specialist is required for a biopharmaceutical company in Cork.
The successful candidate will support external manufacturing operations, working closely with contract manufacturing organisations (CMOs) to ensure continuity of supply across clinical and commercial products.
The role will involve supporting biologics and small-molecule drug product processing, as well as finished goods packaging.
The position will focus on operational readiness, ERP transaction management, and cross-functional coordination to ensure efficient and compliant product supply.
Responsibilities
Execute operational readiness activities to support external manufacturing operations and product supply
Provide support to Process Team Leads across commercial and clinical products, including drug product and packaging activities
Manage and execute ERP transactions related to external manufacturing, including production transactions, work order updates, purchase order receipting, and intercompany transfers
Own and manage change controls and deviations within the Quality Management System, ensuring timely closure with no impact on supply
Consolidate and report key performance metrics across process teams
Provide backup support to Process Team Leads as required
Support continuous improvement initiatives aligned with business objectives, focusing on efficiency and cost savings
Work cross-functionally to perform root cause analysis and implement corrective and preventive actions
Document business processes in standard formats, including SOPs and best practice documents
Identify opportunities to streamline operational processes and reduce manual touchpoints
Support operational activities as required to ensure continuity of supply and business performance
Adapt to changing business needs and support additional activities as required
Qualifications & Experience
Relevant third-level qualification in Supply Chain, Science, Engineering, or related discipline
Minimum 7 years' experience in operations within a regulated or GMP environment
Understanding of biological drug product and/or finished goods packaging processes
Experience working with ERP systems (e.g. SAP)
Strong project management and organisational skills, with the ability to manage multiple priorities
Experience with data analytics tools (e.g. Power BI) desirable
Knowledge of lean, Six Sigma, or continuous improvement methodologies
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