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Details

Operations Lead


Reference:AMC3172 Location: Dublin South
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Executive

AMC3172
Operations Lead
Hybrid - 4 days a week onsite
South Dublin

As the operations lead you will act as a primary production process owner responsible for NPI, Life cycle management, CAPEX and process improvement projects. You will be the operations point of contact for coordination of manufacturing and driving of process efficiencies.

You will need operational and technical knowledge of aseptic drug product manufacturing processes including formulation, parts preparation, formulation, syringe and vial filling, lyophilization and capping

Requirements

  • Bachelors degree in scientific discipline
  • 3+ years experience in biopharmaceutical manufacturing including fill finish exp.
  • Experience in cGMP manufacturing and testing of pharmaceutical products
  • Project management experience and skills
  • Critical thinking and collaboration skills
  • Teamwork and coaching
Responsibilities
  • Primary liaison between product delivery teams and manufacturing operations - collaborating across departments including Facilities & Engineering, Quality, PD, and Supply Chain.
  • Process Improvement activities
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
  • Own and lead change controls as required by the Manufacturing support team
  • Review and approve Bills of Materials
  • Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences
  • Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner
  • Develop, review and approve the following documentation:
    • Generic Master Batch Records
    • Parameter Value Lists for Formulation, Filling, and Inspection processes.
    • Production, Engineering, Operating Procedures & training materials
    • Protocols for manufacturing activities
    • Product Quality Risk Assessments
  • Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing
  • Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects
  • 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
  • Offer troubleshooting assistance during project execution and floor operations, ensuring smooth progress.

If interested in this posting please feel free to contact Angela McCauley on +353 (0)87 693 0951 or angela.mccauley@lifescience.ie for further information.