Revolution Medicines · 4 hours ago
Principal Scientist, Analytical Development
Redwood City, California, United States
Full-time
Hybrid
Lead/Staff
$184K/yr - $230K/yr
12+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Principal Scientist will lead analytical development activities, ensuring alignment with CMC strategies and regulatory submissions while building and mentoring a high-performing team.
Health CareLife ScienceMedical
Responsibilities
Playing a critical role as the analytical development technical lead, the position will be responsible for analytical development activities leading to NDA submission and commercialization, as well as development and execution of the CMC strategy
Lead the development and implementation of analytical strategies to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization
Drive analytical method development, optimization, validation, and troubleshooting, and characterization activities for both drug substances (DS) and drug products (DP)
Develop and oversee quality control strategies, including quality risk management, specifications development, analytical package for DS and DP registration, validation, and commercial readiness
Author and review technical documents, analytical sections of regulatory documents (INDs, IMPDs, NDAs, MAAs, J-NDA, etc.), and responses to regulatory agencies
Stay current with emerging analytical technologies and regulatory trends, drive innovation and continuous improvement across analytical workflows
Build, mentor, and lead a high-performing analytical development team, foster a culture of scientific excellence, collaboration, and accountability both internally and with external partners
Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, clinical pharmacology, and toxicology to ensure alignment and execution of CMC and program objectives
Qualification
Required
PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years
Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry
Proven track record of leading analytical development through all phases of drug development, including NDA/MAA submissions
Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.)
Extensive experience managing CROs and working in a virtual development model
Strong problem-solving skills with strategic and technically sound decision-making ability
Excellent written and verbal communication skills and interpersonal skills
Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment
Preferred
Experience with small molecule oncology drug development
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
2025-12-18
2025-12-18
Company data provided by crunchbase