Software Engineer

• Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science, serving as expert for small-molecule API processes and technologies.
• Provide process engineering support for batch and continuous API platforms from clinical through commercial stages, integrating process chemistry and engineering perspectives.
• Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control.
• Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls.
• Lead technology transfer of API processes between internal sites and external CMOs, ensuring robust, reproducible, and compliant implementation.
• Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation.
• Develop and implement strategies for continuous improvement of marketed API processes, including yield optimization, robustness improvements, cost of goods (COGs) reduction, and capacity expansion.
• Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation.
• Build and oversee a central knowledge base of API process and product understanding, ensuring lessons learned are shared across products, sites, and functions.
• Collaborate closely with GMS functions (e.g., Small Molecules Operations Units, network strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC.
• Provide technical support to marketing applications for global markets and lead preparation of responses to regulatory questions from health authorities.
• Utilize structured root cause analysis techniques to investigate process and equipment issues and deliver robust, sustainable corrective and preventive actions.
• Provide subject matter expertise for due diligence in mergers and acquisitions and in-licensing evaluations.

Associate Director, API Process Engineering

Senior Software Architect