Operations Lead

Summary:
An Operations Lead is required for a biopharmaceutical company in South Dublin. The incumbent will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects.

Responsibilities:

• Function as the site interface between the Product Delivery Teams (PDT’s), and site Manufacturing operations.
• Develop, review and approve generic batch records and parameter value lists across Formulation, Filling and Inspection.
• Develop, review and update Production, Engineering, Operating Procedures & training materials.
• Assist in providing training on scientific or technical aspects of the process/project.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Support scheduling and execution of Characterisation, Engineering and PPQ runs including ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
• Provide troubleshooting support throughout the project and on the floor during execution of activities.
• Hold people to account for delivery and behaviours within Product team.
• Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
• Partner with Learning & Performance to define training strategy’s for NPI’s and complex projects.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences.
• Develop, review and update Protocols for manufacturing activities.
• Documentation and approval of protocol deviations for manufacturing activities.
• Liaise with Process Development regarding process changes in an effective and timely manner.
• Own and lead change controls as required by the NPI Project Team.
• Review and approve bills of materials.
• Develop, review and update Product Quality Risk Assessments.
• Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.

Qualifications & Experience:

• Bachelor’s degree in a science discipline.
• Knowledge of relevant regulations and regulatory requirements (GMP, EH&S).
• 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
• Excellent verbal and written communication skills.
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) and good Presentation skills.