Director, Product Technical Lead

AstraZeneca

Technical Product Lead at Alexion, ensuring technical quality and compliance in pharmaceutical products. Leading cross-functional teams for product lifecycle management and risk mitigation strategies.

Posted 5/26/2026full-timeDublin • 🇮🇪 IrelandSeniorWebsite

About the role

Key responsibilities & impact

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 map, Owner of specification review committees, Owner of product technical risk summary (based on product risk register) in conjunction with product quality risk register
Review 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
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

Requirements

What you’ll need

Degree in scientific or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering: Minimum Bachelor Degree
Demonstrated previous experience in a CMC lead / product technical lead role with demonstrated ability to lead cross functional team in a matrix environment
Extensive technical knowledge of pharmaceutical manufacturing, in Technical, R&D, Process Development, or similar Product Stewardship/Champion roles.
Experience in a combination of areas such as DS/DP processes, combination devices, final packaging, vaccine manufacture, cell and gene therapy, oligonucleotides, and associated relevant background in analytical testing/characterisation
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 clinical/commercial facility, or product development setting
Strong technical writing skills and statistical analysis experience
Ability to travel up to 15%

Benefits

Comp & perks

Professional development opportunities
Flexible working hours

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

bio/pharmaceutical manufacturingprocess engineeringtechnical writingstatistical analysistechnology transferprocess supportanalytical testingcGMP requirementsproduct developmentDS/DP processes

Soft Skills

leadershipcross-functional collaborationrisk managementprocess improvementcommunicationmatrix environment experiencestrategic thinkingproblem-solvingdecision-makingteam management

Certifications

Bachelor Degree in scientific or engineering subject