Principal CMC Data Scientist

Role Summary

Principal CMC Data Scientist. Join the SMOPS team within the PAGE organization to develop and transform genome editing development candidates into therapeutic products. Serve as the CMC data science subject matter expert, applying advanced statistical methodologies across the pharmaceutical development lifecycle, primarily contributing to CPV strategy across modalities including lipid excipients, synthetic oligonucleotides, mRNA, and lipid nanoparticle 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 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 in a matrixed environment to achieve CMC, program, and corporate goals.
• Develop intellectual property, publish scientific papers, and perform other tasks related to the company‚Äôs scientific and business interests.

Qualifications

• Must Have: Experience applying advanced statistical methodologies as a CMC data scientist/statistician in a regulated environment.
• Must Have: Experience with statistical process monitoring/control strategies.
• Must Have: Strong statistical programming skills in R, Python, or other statistical software.
• Must Have: Experience with scale-up, process development, process characterization, process validation, and CPV lifecycle for late-stage pharmaceutical products.
• Must Have: Strong presenter and technical writer; excellent organizational, documentation, and communication skills; ability to work independently or in a matrix team.
• Nice to Have: Experience with regulatory and quality systems requirements for implementation, systems validation, and maintenance of compliant databases and analytics platforms.
• Nice to Have: Experience with lipids, nucleic acids, mRNA and/or LNP drug products and their components.
• Nice to Have: Experience with regulatory submissions and query management.
• Nice to Have: Experience collaborating with external partners (CROs/CMOs) and cross-functional matrix leadership (CMC team or subteam).

Education

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

Experience

PhD in Statistics, Chemical Engineering, Chemistry or related field with 5+ years of CMC data science/statistics experience in a Process Development or late-stage MSAT/Process Analytics role within biotech/pharmaceutical company; or BS/MS with 11+ years of relevant experience.

Physical Requirements

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

Additional Requirements

• Covid-19 vaccination policy: Follow applicable health regulations; vaccination encouraged.
• EEOC statement: Equal employment opportunity; reasonable accommodations as required by law.