Principal CMC Data Scientist

**Principal CMC Data Scientist**In this role, you will be joining the Small Molecule and Oligonucleotide Process Sciences (SMOPS) team, within the larger Process Development, Analytical Development, Genomics, and Engineering (PAGE) organization, helping to develop and transform genome editing development candidates into therapeutic products. As the Principal Chemistry, Manufacturing, and Controls (CMC) Data Scientist, you will be the CMC data science subject matter expert, applying advanced statistical methodologies to support all stages of the pharmaceutical development lifecycle, primarily contributing to continued process verification (CPV) strategy across all modalities associated with Intellia’s *in vivo* program assets (lipid excipients, synthetic oligonucleotides, mRNA, and lipid nanoparticle (LNP) drug products).**Duties/Responsibilities** Performs other related duties as assigned. • Develop intellectual property, publish scientific papers and other tasks related to the Company’s scientific and business interests. **Skills/Abilities** Experience with applying advanced statistical methodologies as a CMC data scientist/statistician, in a regulated environment. Experience with application/implementation of statistical process monitoring/control strategies. Strong statistical programming skills in R, Python, or other statistical software. Experience with the scale-up, process development, process characterization, process validation, and CPV lifecycle for late-stage pharmaceutical products. Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well independently or within a matrix team. Experience with relevant regulatory and quality systems requirements for implementation, systems validation, and maintenance of compliant databases and advanced analytics platforms. Experience with lipids, nucleic acids, mRNA and/or LNP drug products and their components. Experience with regulatory submissions and processes including query management. Experience with routinely collaborating and communicating with external partners (CROs/CMOs).Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team or associated subteam).**Education / Certifications** **Experience** Our ideal candidate will have a PhD in Statistics, Chemical Engineering, Chemistry or related field, with 5+ years of experience or a BS/MS with 11+ years of CMC data science/statistics experience in a Process Development or a late stage MSAT/Process Analytics role within a biotech or pharmaceutical company. **Physical Requirements** #J-18808-Ljbffr

Created: 2025-09-24