Principal CMC Data Scientist

Role Summary

Principal CMC Data Scientist. Join the Small Molecule and Oligonucleotide Process Sciences (SMOPS) team within the PROCESS DEVELOPMENT, ANALYTICAL DEVELOPMENT, GENOMICS, and ENGINEERING (PAGE) organization to develop and transform genome editing development candidates into therapeutic products. 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 in vivo program assets (lipid excipients, synthetic oligonucleotides, mRNA, and lipid nanoparticle (LNP) drug products).

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 enhance 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 used 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‚Äôs scientific and business interests.

Qualifications

• 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 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 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 collaborating with external partners (CROs/CMOs).
• Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team or subteam).

Education

• 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 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.