Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

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.

• Transitioning processes from PPQ to commercial, while leading the CPV and statistical process monitoring/control workstreams.

• Supporting the PAGE teams, by applying data-driven approaches to improve process understanding, performance, and enhancing process capability through process improvement implementation.

• Developing appropriate statistical guidance and work instructions for Intellia, to track, trend, and respond to trend signals within manufacturing.

• Preparing and analyzing complex datasets, used to support manufacturing and analytical investigations, specification setting, quality risk management, annual product quality review (APQR) reporting, and regulatory submissions.

• Partnering with Software Engineering and IT to implement and maintain compliant databases and analytics platforms for CMC data management and visualizations.

• Training and mentoring junior scientists and engineers on advanced statistical methodologies.

• Managing projects and activities both individually and in a matrixed environment, to achieve CMC, program, and corporate goals.

• Develop intellectual property, publish scientific papers and other tasks related to the Company’s scientific and business interests.

Requirements

Skills/Abilities

Must haves:

• 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.

• Strong presenter and technical writer.

• Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well independently or within a matrix team.

Nice to haves:

• 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).

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Education / Certifications

PhD or BS/MS in Statistics, Chemical Engineering, Chemistry or related field

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

Prolonged periods of sitting at a desk and working on a computer.

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