Operations Lead

  • Contract
  • Dublin

Website TPM05531

Summary:
Our client, a biopharmaceutical company located in South Dublin, is looking for an Operations Lead. The successful candidate will serve as a primary production process owner, responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects. 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.

Responsibilities:

  • 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.
  • Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.
  • 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 project(s).
  • 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.

Qualifications & Experience:

  • 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.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.