Operations Lead
Tandem Project Management
- Dublin
- Contract
- Full-time
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, Life Cycle Management Projects or CAPEX projects and established process improvements projects. The successful candidate will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.Responsibilities:
- Function as the site interface between the Product Delivery Teams (PDT's), and Manufacturing operations.
- Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
- 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.
- Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
- Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
- Support scheduling and execution of Characterisation, Engineering and PPQ runs, 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 the Manufacturing Support team and associated with the projects.
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
- Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects.
- Consult 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.
- 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.
- Review and approve Bills of Materials.
- Develop, review and update Product Quality Risk Assessments.
- 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.
- Strong Project Management and organizational skills, including ability to follow assignments through to completion
- Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.
- This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.