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Scientific Technical Lead, Late Stage CMC

AbbVie

North Chicago, IL, United StatesFull TimeSeniorH-1B sponsor company
Sign in to applyVerified 1h ago
Location
North Chicago, IL, United States
Employment
Full Time
Work model
On-Site
Level
Senior
H-1B history
94 approvals (FY2023)
Posted
1h ago

Skills

Machine Learning

About this role

Company Description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

While the AI innovation race in Biopharma is focused on Drug discovery, Product Development/ CMC represents the next barrier/ bottleneck. The complexity of biological systems, the rigor of regulatory expectations, the pace of pipeline growth, and the enormous value at stake make this one of the highest-leverage domains for applied data science and AI in the entire pharmaceutical value chain. We here at BTS - PDST, are building a dedicated, AI-native team that is driving cutting edge programs across early stage, late stage and commercial product development to accelerate E2E product development and launch, maximize yields of block buster products. Through our deep collaboration with PDST scientists we are boldly reimagining how AbbVie can bring our pipeline products and lifesaving drugs to patients faster, safer and in cost effective manner fueled by AI. Late-Stage Biologics Data Scientist is a senior individual contributor role built for a scientist-engineer who thinks in systems, builds with purpose, and leads through technical credibility. This role is a shaper of outcomes. You will embed AI and advanced analytics directly into AbbVie's late-stage biologics pipeline — including process characterization studies, technology transfer to commercial manufacturing sites, process robustness and commercial lifecycle optimization. You will architect data solutions, build and deploy predictive models, and establish the analytical foundation that enables AbbVie to make faster, smarter, more defensible decisions at every stage of commercial biologics development. Enterprise-scale scope: Enterprise-scale biologics portfolio spanning clinical, commercial, and lifecycle stages Building AI playbook for the future: First-in-AbbVie and first-in-biologics analytical approaches; you build the AI playbook for the future Growth and Impact: Direct impact on regulatory submissions, commercial readiness, and manufacturing decisions through deep cross-functional exposure to manufacturing, quality, regulatory, and scientific leadership Mission: Every model you build helps ensure safe, reliable medicines reach patients at scale Responsibilities Process Intelligence & Predictive Analytics Design, build, and deploy predictive and prescriptive models that support process robustness assessment, control strategy optimization, and commercial process validation across late-stage biologics programs. Develop multivariate and time-series modeling approaches to identify critical process parameter interactions, predict process drift, and support proactive deviation prevention at commercial manufacturing sites. Apply advanced statistical and machine learning methods — including dimensionality reduction, anomaly detection, Bayesian inference, and hybrid mechanistic-empirical models — to characterize complex bioprocess behavior and establish meaningful process design spaces. Build and maintain golden batch frameworks and optimization models that serve as living benchmarks for process performance across sites and over time. Technology Transfer & Cross-Site Analytics Lead the development of data infrastructure and analytical tools that enable intelligent, data-driven technology transfer from development to commercial manufacturing — reducing transfer risk and compressing timelines. Build cross-site process intelligence systems that allow PDST and manufacturing

Listing verified 1h ago. Applications go through the company's official careers site.

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Scientific Technical Lead, Late Stage CMC at AbbVie, North Chicago, IL, United States | Yoinka