Associate Director, CMC Technology Delivery

Responsibilities

• Define and execute the IT solutions roadmap aligned with business priorities and digital transformation goals for CMC organizations
• Oversee the implementation and lifecycle management of digital CMC solutions that bring speed-to-market for new pipeline products from declaration of Development Candidate (DC) to regulatory filings for Investigational New Drug (IND) and New Drug Application (NDA) to commercial launch
• Drive implementation of digital and AI/ML capabilities that enable faster and efficient regulatory authoring, bring speed and reduce error rates through digital tech transfer of Drug Substance, Drug Product, analytical methods and data, and drive insights through access to data and analytical capabilities
• Collaborate with CMC and IT Data/AI teams to enable creation, transformation and storage of process recipe master and reference data, transactional data from lab runs, design of experiment (DOE) runs and batch execution runs, and derived data from processing of the results through statistical models and trending outputs
• Deploy digital capabilities that enable structuring and standardizing process recipe data for Critical Process Parameters, Critical Quality Attributes, In-Process Control parameters, Normal Operating Ranges, Proven Acceptable Ranges and allow recipe version management as the chemistry tech transfers from process development to process characterization through site characterization and Process Performance Qualifications (PPQs)
• Partner to develop data assets, AI/digital capabilities for CMC statistics for Process Development and Characterization, Process and Product Control strategy, implementing and supporting lifecycle management of trending tools
• Enable digital capabilities that support CMC Program Management ranging from efficient transfer of programs from R&D to CMC, program start up and advancement enablement, program status reporting
• Partner with CMC, external Contract Manufacturing Organization (CMO), Software and Services partners, and Internal IT organization to develop data products, process templates, procedures and seamless system integrations (API/EDI) to enable efficient exchange of process data
• Proliferate user adoption of data, AI, digital and statistical analytics capabilities to accelerate use cases from research trending to Process Flow Descriptions (PFD) to regulatory specification filing, control strategy drafting, regulatory question responses to supporting commercial manufacturing for process control and monitoring, investigations and process optimization
• Partner with the IT Data/AI team and the CMC organization to establish process data governance, process data stewardship, and process data products on the enterprise data platform to enable analytics and AI/ML capabilities for CMC operations
• Own end-to-end accountability for the lifecycle of CMC applications - from strategy and design through deployment, sustainment, upgrades, continuous improvement, and retirement. Partner with the business to define business case and articulate outcomes, manage total cost of ownership of digital solutions
• Ensure systems meet GxP, data integrity, and global regulatory requirements (e.g. FDA 21 CFR), maintaining audit readiness
• Drive operational excellence by ensuring reliability, performance, compliance, and high-quality support of CMC systems (e.g., Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision)
• Lead and mentor a team of cross-functional and IT resources
• Oversee end-to-end delivery of initiatives and build strong partnerships with business stakeholders, IT teams, vendors, and procurement

Qualifications

• Bachelor’s degree in Science, Engineering, Information Technology or related field
• 10+ years of experience in CMC, Process Engineering or IT client-facing roles for CMC and Process/Analytical Development organizations in biopharmaceuticals or life sciences industry
• Experience with some of the following: regulatory filing process, understanding of recipe unit operations and data structures, statistical software and analytical trending tools (e.g. multi-variate data analysis, assay and control charts, JMP, Minitab, R, Python, SIMCA batch-on line, SEEQ, etc.)
• Exceptional stakeholder management and influencing skills with operations leaders and scientist user base. Change management and transformation leadership
• Experience with data and systems integration, analytics, working with system integrators and managing IT suppliers
• Experience in regulated environments (GxP, computer systems validation, FDA 21 CFR regulations)
• Demonstrated success building and leading cross-functional teams
• Strategic mindset with a pragmatic approach - balancing long-term vision with reliable delivery of measurable business outcomes
• 10% travel maybe required