Product Technical Lead

Role Overview

• 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
• Perform process capability analysis (periodic basis) and provide recommendations, in support of APQRs and product reviews
• Review CPV plans and outputs reports for recommendations
• Serve as an empowered Alexion Technical Operations representative working collaboratively and cross-functionally...

Requirements

• 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&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
• Extensive technical knowledge of commercial manufacturing with experience with biologics or small molecule, or development manufacture
• 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
• 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
• Ability to travel up to 15%

Benefits

• Health insurance
• Professional development opportunities