The Opportunity:

• Serve as a key analytical development SME, providing strategic leadership on phase appropriate control strategies for API and drug product, including specification setting, analytical method development, and lifecycle management.
• Lead and drive day to day analytical activities supporting the development, characterization, and manufacturing of API and drug product, while actively contributing to cross functional PDM project teams.
• Author and review Quality sections of regulatory submissions, and effectively address queries from regulatory agencies.
• Evaluate, select, and implement appropriate analytical technologies and strategies, while managing external partners including CDMOs and contract testing laboratories for analytical method development, validation, transfer, release testing, and investigation/resolution of OOS/OOT events.
• Prepare, review, and approve technical protocols, reports, specifications, and supporting documentation to ensure scientific rigor and regulatory compliance.
• Partner closely with cross functional teams including Drug Product, Drug Substance, Regulatory Affairs, QA, Project Management, Medicinal Chemistry, DMPK, and Toxicology to advance project milestones and enable timely achievement of development goals.

Required Skills, Experience and Education:

• PhD (minimum MS) in Analytical Chemistry, Organic Chemistry, or a related scientific discipline.
• 10+ years of experience in analytical development within the pharmaceutical or biotechnology sector.
• Demonstrated success leading cross functional projects with strong organizational and execution skills.
• Extensive hands on and strategic leadership experience supporting analytical activities across small molecule drug development, preferably with depth in late-phase development and commercialization readiness.
• Excellent communication and influencing skills, including verbal, written, and presentation abilities, coupled with strong collaboration, planning, and people leadership capabilities.
• Deep scientific and technical understanding of CMC strategies and analytical enablement for small molecule development programs.
• Proven experience managing external partners, including CROs and CDMOs, to ensure high quality deliverables and program execution.
• Working knowledge of global regulatory requirements and experience supporting regulatory submissions, including INDs, IMPDs, NDAs, and/or MAAs.
• Comprehensive understanding of ICH guidelines, GMP regulations, and current industry best practices related to analytical development and quality.
• Strong critical thinking and innovation mindset with the ability to independently evaluate complex issues, identify risks, and implement effective solutions.
• Excellent technical problem-solving skills with sound scientific judgment and data driven decision-making capabilities.
• Ability to effectively prioritize multiple responsibilities and thrive in a dynamic, fast paced, and highly collaborative environment.

Preferred Skills:

• PhD in Analytical Chemistry, Organic Chemistry, or a related scientific discipline.
• Project leadership and CDMO oversite experience.
• Late phase development and regulatory submission.

#LI-CT1 #LI-Hybrid

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

Please note that base pay salary range 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.

Base Pay Salary Range

$190,000-$238,000 USD

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.

Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

If you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.