Analytical Development Technical Lead

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

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. The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure analytical development and CMC activities are executed seamlessly and in alignment with the integrated CMC development plan and program timelines.

Responsibilities:

• 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 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.

Required Skills, Experience and Education:

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 18+ years of industry experience; or MS with 20+ 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.
• Excellent leadership, project management, and cross-functional collaboration skills.
• 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 Skills:

• Experience with small molecule oncology drug development.

The base salary range for this full-time position is $236,000 to $295,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.