Associate Director, CMC Technology Delivery

Role: Associate Director, CMC Technology Delivery, leading digital enablement and transformation of biopharma CMC operations from preclinical to commercial phases. Responsibilities include defining and executing digital strategies, implementing digital solutions for process sciences, analytical sciences, and program management, and integrating AI/ML capabilities to accelerate regulatory filings and manufacturing processes. The role entails managing digital systems lifecycle, ensuring GxP compliance, and fostering operational excellence through systems reliability and support. Collaboration involves partnering with CMC teams, IT, vendors, and external CMOs, with a focus on data governance, system integration, and user adoption. Qualifications: Bachelor’s in Science, Engineering, or IT; 10+ years in CMC, process engineering, or IT roles within biopharma/life sciences; experience with regulatory processes, data structures, statistical tools, and GxP environments. Preferred: Master’s, PhD, or MBA; familiarity with data integration, APIs, AI, Agile methodologies, and emerging digital tech. Expectations: hybrid in Cambridge, MA, with up to 10% travel. High-value biopharma specifics include focus on process data, regulatory compliance, digital transformation, and AI applications across drug substance, drug product, and analytical sciences.