Senior Director, Analytical Development, Testing and Lab Automation

Key Duties And Responsibilities

• Provide strategic leadership for the Testing, Operations, and Automation Analytical Development function across multiple programs
• Establish and drive testing strategies using manual and automated methods to support process development, process characterization, and stability studies to build process/product understanding and inform control strategies
• Lead and oversee teams responsible for the development, optimization, and qualification of automated and PAT analytical methods and end-to-end automation platforms for process development and analytics
• Lead the establishment of laboratory informatics for highly automated equipment and digitization projects supporting data trending and visualization platforms that support interpretation of analytical datasets, including AI and machine learning tools
• Establish and manage critical assay reagents, assay controls, and control charts to ensure optimal assay performance
• Set and reinforce operational best practices across analytical development, including sample management, data management, data integrity, documentation in notebooks and reports, and training
• Build strong cross-functional and external partnerships to advance analytical and program goals
• Author and review technical and scientific documents, including presentations, study protocols, reports, and test methods
• Recruit, mentor, and develop organizational talent while managing department resources, budget, and headcount

Knowledge And Skills

• Extensive experience establishing and leading analytical testing teams, including establishment of testing strategies that include manual and automated methods
• In-depth experience and aptitude in laboratory informatics and implementation of AI/machine learning tools for laboratory automation, partnering with Digital/IT functions
• In-depth experience with automation of analytical method development, optimization, and qualification and end-to-end automation platforms supporting process development and analytics
• In-depth experience with digitization projects including data trending and visualization platforms to support interpretation of datasets
• Knowledge of product characterization testing and analytical procedure implementation. Experience supporting PAT method development, process development, process characterization, and stability studies
• Expertise in sample management, data management, and data integrity practices
• Experience managing critical assay reagents, assay controls, and control charts
• Strong understanding of ICH, FDA, and USP guidelines, and ability to apply them in the context of pharmaceutical development stage
• Experience authoring and reviewing study protocols, reports, test methods, and regulatory-supporting documentation

Education And Experience

• Masters degree or PhD in relevant discipline (analytical chemistry, immunology, biochemistry, cell biology, biotechnology or related field) with progressive experience in technical leadership roles in the pharmaceutical industry
• Experience with Cell Therapy, Biologics, and Genetic therapies is critical
• Ph.D. (or equivalent degree) and 11+ years of relevant post-doctoral employment experience, orMasters Degree (or equivalent degree) and 15+ years of relevant employment experience

Pay Range

$226,100 - $339,100