Scientific Technical Lead, Early Stage PDST CMC (AI)

Location: North Chicago, Illinois, United States

Salary: $109,500–$208,500 per year

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Develop, validate, and deploy predictive models for early-stage biologics process development, including upstream performance, downstream purification, and critical quality attributes.
• Design hybrid models that combine first-principles process knowledge with data-driven methods, supporting digital twins and in-silico process optimization.
• Define data strategies, improve data quality and integration, and build traceable analytical assets aligned with GxP principles and regulatory expectations.
• Architect and validate statistical, machine learning, retrieval-augmented, and orchestrated AI workflows for scientific applications.
• Design statistically rigorous experiments using DoE, Bayesian optimization, and active learning, and support process characterization and risk assessment.
• Communicate quantitative findings to scientists, engineers, quality professionals, and senior leaders, including documentation for technical reviews and regulatory submissions.

Requirements

• Bachelor’s degree with 7 years of relevant experience, master’s degree with 6 years, or PhD with 2 years in computer science, IT, application development, or a related discipline.
• Hands-on experience building and deploying data science or machine learning solutions in scientific or engineering environments.
• Expert Python skills and experience with NumPy, pandas, scikit-learn, PyTorch or TensorFlow, cloud platforms, big data, and pipeline orchestration.
• Experience with R, Dataiku, AWS SageMaker, Spark, Tableau, DoE, Bayesian methods, or active learning.
• Experience in a GxP-regulated environment, including FDA/EMA expectations, process validation, continued process verification, and control strategy.
• Experience with MLOps, model lifecycle management, regulated analytics, or enterprise deployments.

Nice to have

• Advanced degree in data science, biostatistics, chemical or biochemical engineering, computational biology, or a related quantitative discipline.
• Experience with LIMS, MES, DeltaV or historian systems, eBR platforms, and scalable process-analytics pipelines.
• Experience in biologics or bioprocess development, including cell culture, fermentation, chromatography, filtration, or formulation.
• Knowledge of CMC development, scale-up, technology transfer, regulatory filing support, or commercial process validation.
• Scientific publications, regulatory submissions, technical reports, or equivalent scientific communication experience.

Culture & Benefits

• Enterprise-scale work spanning clinical, commercial, and lifecycle biologics development.
• Direct impact on regulatory submissions, commercial readiness, manufacturing decisions, and medicine supply.
• Paid time off, holidays, sick leave, medical, dental, and vision insurance.
• 401(k) and eligibility for long-term incentive programs.
• Cross-functional collaboration with manufacturing, quality, regulatory, engineering, and scientific leadership.