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Associate Director – Process Data Analytics & Capabilities

Location Dublin, Leinster, Ireland Job ID R-200486 Date posted 24/05/2024

The Alexion Technical Operations (ATO) team support Alexion’s global manufacturing operations across both internal and external sites. The ATO team delivers experienced technical leadership, process knowledge and rapid solutions to ensure delivery of Alexion’s product pipeline, and product technical leadership post-commercialisation.

This is what you will do:

The Process Data Analytics & Capabilities lead is responsible for digital transformation of our manufacturing process and product data/knowledge at Alexion Operations. This is achieved by:

Establishing and maintaining the right capabilities/systems to assemble & present manufacturing process and product data/knowledge. Having the expertise to use data/knowledge to gain a deeper understanding of our processes and products.   Continuously advancing and improving 1 & 2.  

In partnership with Manufacturing Systems and IT the team design and build infrastructure to capture process data, improve process knowledge and enable fast, inquisitive and proactive data-driven decisions. 

The team serves as a center of excellence for process and product data analysis, process knowledge and statistical assessments in support of manufacturing process and analytical testing improvements. This includes support for regulatory filings, major changes to process and analytical testing.  The PDAC lead will drive continuous improvement of process knowledge and product data analytics capabilities across the organization. 

You will be responsible for:

  • Leading the PDAC team within Alexion Technical Operations.
  • Defining and maintaining the multi-year strategic roadmap for digital transformation and advancing Alexion’s process knowledge.
  • Project Leader for introduction of Enterprise Data Analytics software within the network for automated data collection, analysis and sharing, as well as definition of the overall business processes.
  • Accountable for the development, maintenance, upgrade of enterprise data assets and models (e.g. Discoverant Hierarchies, SIMCA Models)
  • Leading matrixed team(s) in collaboration with Manufacturing Systems and Information Technology in the introduction of new technology to improve process/product knowledge and Product Data Analytics & Capabilities (e.g. digital twin, advanced dashboarding for process monitoring, AI, etc.)
  • Accountable for statistical analysis/support for Alexion Operations, which includes:
    • Process capability analysis.
    • Statistical support for complex investigations, regulatory submissions, health authority requests.
    • Shelf-life analysis, justification for extension.
    • Specification changes/reassessment methodology and support.
    • Design of experiments (DOE) support.
    • Multi-variate analysis (MVA) in support for complex process investigations and/or evaluating opportunities to increase yield and process robustness.
  • Ownership of the comparability guideline and comparability analysis support, including both process comparability, product release comparability, and stability comparability.
  • Global QC data analytical support and APQR content authoring including trending and analysis of stability and release data, management of the stability trending program.  The team also supports the setting of acceptance criteria for reference standards.
  • The team is responsible for training and support to ATO, internal site Technical Services, and QC on use of statistical software (JMP).
  • Supports the preparation and management of annual budgets for the PDAC team.

You will need to have:

  • >5 years’ experience in a technical function, supporting Bio-manufacturing.
  • Experience with knowledge management and data analytics software (e.g. Discoverant, Statistica) and multivariate analysis (SIMCA).
  • Basic knowledge of statistical tools and methodologies.
  • People management skills.

We would prefer for you to have:

  • Bachelors’ degree in life sciences or engineering (or related field).
  • Training in data science, data analytics and/or statistics would be an advantage.
  • Six Sigma training/certification.  
  • Project management skills.
  • Business and strategic skills.

Competencies

  • Flexibility and strong attitude toward teamwork and collaboration, with ability to build effective relationships both within and external to the department.
  • Cross-functional Influencing skills.
  • Ability to lead and operate efficiently in a complex matrix organization.
  • Enthusiasm, proactivity, strong attitude for continuous improvement and innovation.
  • Ability to see the full picture and anticipate long term impact of changes & future needs.

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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