Process Optimisation Lead

1 month ago

Dublin, Ireland AstraZeneca GmbH Full time

In Alexion BDS Technical Services, we work closely with Alexion Dublin Manufacturing Facility (ADMF) partners, including Operations, Techincal Operations, Quality, Supply Chain, and MSAT to provide technical leadership and ensure delivery of quality products to our patients and support our product pipeline. The Process Optimisation Lead (POL) will be responsible in delivering process optimisation across the current and future commercial products that will be manufactured in ADMF. As the technical product expert, the incumbent will Identify and Lead process improvement projects to deliver on process yields and takt time improvements and lead the implementation of new process analytical platforms for the BDS. The successful canddate will proactively implement projects to minimize technical risks, through early detection and mitigation of same during commercial manufacturing and technology transfer activities. The POL will act as the technical liaison within BDS TS, working with Alexion Technical Operations (ATO), Product Technical Leads (PTL), Process Development, and other functions to ensure that ADMF delivers process improvements in line with Supply Chain targets. Provides the digital tools, data and knowledge to manufacturing technologists in operations and TS sustaining support teams to enable them to understand process performance in real-time and facilitate informed process decision making to optimize yield and process performance and avoid deviation vs control strategy.

The role bridges efficient communication, project management and decision making related to the technical quality of our products, including the identification and mitigation of process improvements and reducing risk across our products.

You will be responsible for:

  • Be the BDS technical lead for Process Optimisation related to Titre, Yield, and takt time.
  • Maintain knowledge and history of the product(s) process throughout the BDS
  • Project Management of process optimisaitons projects for current and future commercial products :
    • Identification of Process Improvement projects
    • Owner of implementation road map
    • Owner of Yield Council including readout of active and future projects
  • Work collaboratively and cross-functionally within the BDS and externally with Regulatory, Supply Chain, ATO, PTLs, and Strategic Product Leads
  • Support Operations by providing technical expertise for investigation and resolution of process deviations with internal/external manufacturing, through authoring/ review and mentoring on key risk assessments
  • Proactively manage risk and drive product related decisions to ensure the Product team is successful in achieving improvement goals
  • Identify and lead through to approval, opportunities for process/operational improvements that can be replicated and implemented across the internal and external manufacturing network
  • Collaborate with ATO and Process Engineering to design, implement and maintain robust process improvement projects
  • Own the implementation of new process analytical platforms within the BDS such as SIMCA, Discoverant and related platforms in support of commercial manufacturing investigation and process improvement identification
  • Author, review and approve techincal assessment and change controls

You will need to have:

  • Degree in scientific or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering:
    • B.S with >8 years of experience
  • Extensive technical knowledge of pharmaceutical manufacturing, in Technical, or Process Engineering areas
  • Demonstrated experience in identifying and implementing technical process improvements to improve yield, reduce cost and / or improve takt time.
  • Extensive technical knowledge of commercial drug substance manufacturing with direct experience with biologics manufacturing or development
  • Comprehensive understanding of cGMP requirements and the ability to implement best practices to ensure technical excellence
  • Expertise in successful execution and management of technology transfer, process support within a commercial facility
  • You will present/defend technical and scientific approaches in both written and verbal form, including during regulatory agency inspections
  • Excellent communication skills with the ability to successfully influence across levels, across functions, with senior leaders and technical leaders
  • Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities
  • Strong technical writing skills and statistical analysis experience
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others, maintain general availability during standard business hours

We would prefer for you to have:

  • Masters / advanced degree is preferred
  • Experience of statistical analysis, and software packages (e.g., JMP)
  • High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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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