Advisor, Data Scientist - CMC Data Products

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work worldwide to discover and bring life‑changing medicines, deepen the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. Organizational & Position Overview The Bioproduct Research and Development (BR&D) organization strives to deliver creative medicines to patients by developing and commercializing insulins, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies, and gene therapy systems. This multidisciplinary group works collaboratively with our discovery and manufacturing colleagues. Responsibilities Data Product Development: Define the roadmap and deliver analysis‑ready and AI‑ready data products that enable AI/ML applications, PAT systems, near‑time analytical testing, and process intelligence across CMC workflows. Data Archetypes & Modern Data Management: Define pharmaceutical‑specific data archetypes (process, analytical, quality, CMC submission) and create reusable data models aligned with industry standards (ISA‑88, ISA‑95, CDISC, eCTD). Modern Data Management for Regulated Environments: Implement data frameworks that ensure 21 CFR Part 11, ALCOA+, and data‑integrity compliance while enabling scientific innovation and self‑service access. AI/ML‑ready Data Products: Build training datasets for lab automation, process optimisation, and predictive CQA models, and support generative AI applications for knowledge management and regulatory Q&A. Cross‑Functional Leadership: Collaborate with analytical R&D, process development, manufacturing science, quality, and regulatory affairs to standardise data products. Deliverables Include Scalable data integration platform that automates compilation of technical‑review‑ready and submission‑ready data packages with demonstrable quality assurance. Unified CMC data repository supporting current process and analytical method development while enabling future AI/ML applications across R&D and manufacturing. Data flow frameworks that enable self‑service access while maintaining GxP compliance and audit readiness. Comprehensive documentation, standards, and training programmes that democratise data access and accelerate product development. Basic Requirements Master’s degree in Computer Science, Data Science, Machine Learning, AI, or a related technical field. 8+ years of product‑management experience focused on data products, data platforms, or scientific data systems and a strong grasp of modern data‑architecture patterns (data warehouses, data lakes, real‑time streaming). Knowledge of modern data‑stack technologies (Microsoft Fabric, Databricks, Airflow) and cloud platforms (AWS‑S3, RDS, Lambda/Glue, Azure). Demonstrated experience designing data products that support AI/ML workflows and advanced analytics in scientific domains. Proficiency with SQL, Python, and data‑visualisation tools. Experience with analytical instrumentation and data systems (HPLC/UPLC, spectroscopy, particle characterisation, process sensors). Knowledge of pharmaceutical manufacturing processes, including batch and continuous manufacturing, unit operations, and process control. Expertise in data modelling for time‑series, spectroscopic, chromatographic, and hierarchical batch/lot data. Experience with laboratory data‑management systems (LIMS, ELN, SDMS, CDS) and their integration patterns. Additional Preferences Understanding of Design of Experiments (DoE), Quality by Design (QbD), and process validation strategies. Experience implementing data mesh architectures in scientific organisations. Knowledge of MLOps practices and model deployment in validated environments. Familiarity with regulatory submissions (eCTD, CTD) and how analytical data supports marketing applications. Experience with CI/CD pipelines (GitHub Actions, CloudFormation) for scientific applications. Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, colour, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $244,200. Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance programme, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programmes in its sole discretion, and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Location: Indianapolis, IN. #J-18808-Ljbffr Eli Lilly and Company