Scientific Technical Lead, Late Stage CMC
Listed on 2026-08-22
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IT/Tech
AI Engineer (Applied/Software), Data Engineering, Machine Learning/ ML Engineer, Data Scientist
About Abb Vie
Abb Vie'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 Abb Vie, please visit us at Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
CompanyDescription About Abb Vie
Abb Vie'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 Abb Vie, please visit us at Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
Job DescriptionWhile 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 Abb Vie can bring our pipeline products and lifesaving drugs to patients faster, safer and in cost effective manner fueled by AI.
- Enterprise-scale scope:
Enterprise-scale biologics portfolio spanning clinical, commercial, and lifecycle stages - Building AI playbook for the future:
First-in-Abb Vie 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
- 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.
- 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 teams to compare, contextualize, and act on process data across geographically distributed sites and diverse equipment trains.
- Partner with manufacturing science and quality teams to define data requirements, establish data standards, and ensure analytical continuity from process development through commercial operations.
- Serve as a solution architect for AI and analytics initiatives within PDST — evaluating problems…
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