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Assoicate Director Drug Substance, Alexion Technical Operations (ATO)

Location Dublin, Leinster, Irlande ID de l'offre R-203105 Date de publication 06/21/2024

This is what you will do:

Responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by Alexion for production of commercial products.  This position provides strong scientific leadership for all aspects of technology transfer, validation, commerical manufacturing, process scale-up, inspections, process monitoring, and process troubleshooting for drug substance manufacturing activities.

The position, fosters effective cross-functional working relationships with internal and external groups in operations, Process Development and Analytical sciences for the technology transfer of new products. The role provides leadership and mentoring to the external technical services drug substance team

You will be responsible for:

  • Leading and building the external drug substance team
  • Provide technical leadership and direction for transferring new products and processes. 
  • Lead risk assessments in support of new product implementation and provide direction and significant technical input for DFM (Design for Manufacturability) initiatives.
  • Plan and handle day-to-day technical support work to meet manufacturing or CMO shutdown schedules while supporting a high level of GMP compliance at the CMOs.
  • Provide input to Technical Services project schedule on a weekly, monthly, and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet company goals and metrics, as required.  This includes continuous communication with internal partners (Quality Assurance, Supply Chain, Process Development and Analytical Sciences) to ensure efficient management of Alexion's commercial product manufacturing.
  • Provide guidance to process validation program for all drug substance manufacturing processes at CMOs.
  • Provide technical input to Process Development for defining the critical process parameters of new processes.
  • Author technical documents for regulatory agency submission in support of process transfers. Serve as a subject-matter expert on technology transfer and process support during regulatory agency inspections.
  • Provide technical leadership and direction for process monitoring and statistical analysis of manufacturing operations.
  • Provide significant technical depth to support troubleshooting efforts and lead high-level deviation investigations in conjunction with Alexion QA and CMO Manufacturing and Quality groups.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of Manufacturing.
  • Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail.  Communications will be both written documents and oral presentations.
  • Up to 20% international travel may be required

You will need to have:

  • Comprehensive understanding of Technical/cGMP requirements for commercial manufacturing of Drug substances.
  • Excellent communication and influencing skills enabling them to influence both internal and external partners.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Advanced degree or equivalent experience in engineering or comparable industry experience.
  • Leadership of technical projects or teams.

We would prefer for you to have:

  • Knowledge of cell and gene therapy manufacturing technoglies
  • Medium size molecule manufacturing

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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