Senior Director, Analytical Development, Testing and Lab Automation

The Senior Director, Analytical Development is a senior leadership role within the Cell and Gene Therapy Analytical Development function and will be responsible for setting and driving the company’s analytical testing strategy, including manual and automated testing approaches, analytical operations, and implementation of automation capabilities. This leader will oversee teams focused on automation of assays, testing in support of process work streams, and analytical operations such as reagent and assay control management.

The role will work closely with Manufacturing, Process Development, Regulatory, Quality, CMC, and external partners to generate high-quality data that informs strategy and decisions, while advancing next-generation analytical automation tools for characterization of cell, gene and biologic therapy processes and products. This position will also shape broader analytical strategy across multiple programs and build organizational capability through strong scientific and people leadership.

• 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 (~70% of team resources)
• 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 (~20% of team resources)
• 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. (~5% of team resources)
• Establish and manage critical assay reagents, assay controls, and control charts to ensure optimal assay performance (~5% of team resources)
• 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

• 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

• Self-driven and recognized as a laboratory digitization champion
• Proven track record of people leadership and managing high throughput testing
• Ability to lead in a fast-paced environment, manage competing priorities, and maintain timelines across multiple activities
• Strong scientific depth within one’s discipline, with a broad understanding of adjacent scientific disciplines and the drug development process
• Excellent written, verbal, interpersonal, and matrix leadership skills
• Ability to influence internal and external stakeholders and work effectively both independently and in team environments
• Scientific leadership marked by high ethical standards and broad peer respect
• Extensive experience establishing and leading analytical testing teams, including establishment of testing strategies that include manual and automated methods

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…