Principal CMC Data Scientist

Overview

Join to apply for the Principal CMC Data Scientist role at BioSpace .

In this role, you will be the CMC data science subject matter expert within 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.

You will apply 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.
• Support the PAGE teams by applying data-driven approaches to improve process understanding, performance, and enhancing process capability through process improvement implementation.
• Develop appropriate statistical guidance and work instructions to track, trend, and respond to trend signals within manufacturing.
• Prepare and analyze complex datasets to support manufacturing and analytical investigations, specification setting, quality risk management, APQR reporting, and regulatory submissions.
• Partner with Software Engineering and IT to implement and maintain compliant databases and analytics platforms for CMC data management and visualizations.
• Train and mentor junior scientists and engineers on advanced statistical methodologies.
• Manage 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).

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.

Covid-19 Vaccination Policy

All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

EEOC Statement

Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.