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.
Early-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 early-stage biologics pipelines including process characterization studies, process robustness, and control strategy development. 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:
Modeling & Predictive Analytics
- Develop, validate, and deploy predictive models that support process development decisions in early-stage biologics, including upstream bioprocess performance, downstream purification behavior, and critical quality attribute (CQA) outcomes.
- Design and apply hybrid modeling approaches — combining first-principles process understanding with data-driven techniques — to maximize predictive power while maintaining scientific interpretability.
- Build and evolve analytical frameworks that support digital twin concepts and in-silico process optimization, enabling smarter experimental strategies and accelerated development timelines.
Data Strategy & Architecture
- Partner with process scientists, analytical scientists, and engineers to define data strategies for new programs — including what data to collect, how to structure it, and how to connect it across experimental campaigns.
- Identify and address data quality, integration, and accessibility challenges that limit the value of existing datasets; advocate for and help implement improved data infrastructure within the pod.
- Ensure that models, analyses, and data assets are built in a manner consistent with GxP principles and regulatory expectations, with appropriate documentation and traceability.
Intelligent Workflow Design
- Function as a solution architect for analytical and AI-driven workflows: select the right approach for each problem — whether that means classical statistical methods, supervised or unsupervised machine learning, retrieval-augmented generation, multi-step orchestrated AI pipelines, or hybrid mechanisms — based on scientific need, data availability, and interpretability requirements.
- Identify opportunities to automate, accelerate, or augment scientific workflows using intelligent tooling, and take ownership of scoping, building, and validating those solutions.
- Stay current with the rapidly evolving landscape of AI and machine learning methods; evaluate emerging approaches for applicability to biologics development contexts.
Experimental Design & Decision Support
- Collaborate with process development scientists to design experiments that are statistically rigorous, resource-efficient, and maximally informative — including design of experiments (DoE), Bayesian optimization, and active learning strategies.
- Support process characterization studies by providing statistical analysis, model-based risk assessment, and data-driven identification of critical process parameters (CPPs) and their relationships to CQAs.
- Contribute to technology transfer readiness by developing robust analytical frameworks that translate process understanding into transferable, defensible process knowledge.
Stakeholder Engagement & Scientific Communication
- Translate complex quantitative analyses into clear, actionable insights for scientists, engineers, and senior leaders — bridging technical depth with business relevance.
- Actively participate in cross-functional discussions, contributing data-driven perspective to program decisions, risk assessments, and development strategies.
- Document, present, and defend analytical work in a manner appropriate for internal technical reviews and regulatory submissions.