Job Title:
Operations Lead
About the Role:
We are seeking an experienced Operations Lead to join our South Dublin based Biopharmaceutical company. The successful candidate will be responsible for managing secondary manufacturing activities, including Formulation, Fill Finish and Packaging.
Key Responsibilities:
• Act as the site interface between Product Delivery Teams (PDTs) and Manufacturing operations.
• Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
• Develop, review and update Production, Engineering, Operating Procedures & training materials.
• Document and approval of protocol deviations for manufacturing activities.
• Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
• Own and lead change controls as required by the Manufacturing support team.
About You:
• Bachelor's degree in a science discipline.
• 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply.
Benefits:
Work From Home