Role can be based from Athlone, Cork or Dublin site.
Introduction to role: In Alexion Technical Operations (ATO), we work closely with Alexion's manufacturing network of internal sites and external manufacturing partners, our colleagues in Development, Quality, Regulatory, Supply Chain, and Commercial Operations to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline.
The Product Technical Lead (PTL) is responsible for providing company-wide technical leadership of Alexion's commercial products throughout the product lifecycle.
As the technical product expert, the incumbent will build and implement strategy to proactively minimize technical risks, through early detection and mitigation of same during late-stage commercialisation, technology transfer activities, and commercial operations.
The PTL is the technical liaison within Alexion Technical Operations, working with, Site Technical Services, Regulatory Affairs, Operations, Quality Assurance, Quality Control, Process Development, Supply Chain, Finance, and other functions to ensure regulatory compliance, best in class technical manufacturing, and associated testing processes.
The role bridges efficient communication, technical insights, and decision making related to the technical quality of our products, including the identification and mitigation of risk, and supporting continual technical improvement initiatives across the sites manufacturing our products.
You will be responsible for: Be the company-wide technical lead for assigned (bio)pharmaceutical product(s) of the portfolio encompassing a variety of modalities, primarily drug substance, raw materials through drug product packaging and associated testing of manufactured products Maintain knowledge and history of the product(s) process throughout the entire commercial lifecycle, inclusive of development history Perform process management in the following areas (but not limited to):Owner of product improvement road mapOwner of specification review committeesOwner of product technical risk summary (based on product risk register) in conjunction with product quality risk registerPerform process capability analysis (periodic basis) and provide recommendations, in support of APQRs and product reviewsReview CPV plans and outputs reports for recommendations Serve as an empowered Alexion Technical Operations representative working collaboratively and cross-functionally with Strategic Product Leads and Product Team members contributing to product vision, technical strategy, technical business cases, plans, and delivery - must consult with functional leaders and bring Operations view to the table to support decision-making and planning 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 for replication and implementation across the manufacturing network Collaborate with Technical Services (internal/external) to design, implement and maintain robust process control strategies for products during Technology Transfer and commercial manufacture stages.
Author, review and approve CMC sections of regulatory agency submissions, responses (IRs), supporting successful regulatory agency inspections by providing subject-matter expertise on technology transfer, and process, to support the technical content of filings and ensuring flexibilities built in to minimize impact of future process changes Serve as the empowered Operations representative on CMC Product teams for late-stage clinical products to ensure delivery of commercial products that are consistent with Operations long term strategies You will present/defend technical and scientific approaches in both written and verbal form, including during regulatory agency inspections Define, implement, and improve business processes for technical aspects of product lifecycle management Define the methodology and approaches for developing business cases for lifecycle improvement projects, considering technical, financial, supply and regulatory aspects Embed Digital solutions/AI into PTL related workflows that enables reduction in NVA Capture and embed lessons learned from commercial experience back into late stage filing approach, reducing technical risks for continued commercial supply and on time approvals Support Alexion Strategic Initiatives Mentor and develop talent of the future Serve as Technical SME for core identified area/topic.
Essential Skills / Experience: Degree in scientific or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering: Minimum Batchelors Degree Demonstrated previous experience in a CMC lead / product technical lead role with demonstrated ability to lead cross functional team in a matrix environment Demonstrated ability to build new organisations or business processes Extensive technical knowledge of pharmaceutical manufacturing, in Technical, R