Scientific Technical Lead, Late Stage CMC

Role: Senior Data Scientist specializing in biologics process analytics within AbbVie's late-stage pipeline. Objectives include embedding AI and advanced analytics into biologics development, manufacturing, and lifecycle management to accelerate product timelines, enhance process robustness, and support regulatory and commercial decisions. Responsibilities encompass designing predictive models for process validation, process control optimization, and transfer risk reduction; developing cross-site data infrastructure; establishing AI solution frameworks compliant with GxP standards; and defining data strategies aligned with regulatory requirements. The role involves close collaboration with manufacturing, quality, regulatory, and scientific teams, translating complex analytical insights into actionable outcomes, and mentoring junior staff. Qualifications: requires a PhD or master’s in Data Science, Bioengineering, or related field with 2+ (PhD) or 6+ (MS) years of experience in implementing data science solutions, preferably in biologics or pharma manufacturing environments. Expert proficiency in Python, statistical modeling, machine learning, and familiarity with regulated environments (FDA/EMA) is necessary. Preferred: advanced degrees, extensive biologics manufacturing or process development experience, and a track record of scientific publications or regulatory submissions. High-value specifics include focus on biologics, process characterization, technology transfer, and process validation in late-stage clinical and commercial settings. The position is strategic, impacting AbbVie's biologics portfolio across development and manufacturing stages.