Associate Director, Analytical Development & QC

Revolution Medicines; Redwood City (CA); On-site; USD 186,000 - 233,000; Full time

Job summary

Revolution Medicines, a Redwood City, CA based oncology company, seeks an Associate Director of QC to oversee contract-lab testing for drug substances, products, and stability across development and commercial programs.

You will lead method transfers, validations, data oversight, and handling regulatory submissions, while collaborating with QA, CMC RA, DS/DP, and Supply Chain to meet timelines and quality standards.

Qualifications

• Bachelor’s degree with 15+ years in pharmaceutical QC across development and commercial stages.
• Master’s degree with 12+ years; PhD with 10+ years acceptable.
• Strong knowledge of global regulatory guidelines (FDA, EU, ICH) and cGMP practices.
• Experience with regulatory submissions (IND, IMPD, NDA, MAA).

Responsibilities

• Lead and/or coordinate QC activities for late-phase and commercial programs, including launch readiness and release testing.
• Oversee outsourced QC activities at CDMOs/CTLs.
• Manage quality events such as investigations, deviations, CAPAs, and change controls.
• Author/review QC documents including methods, protocols, reports, memos.
• Manage commercial phase reference materials and retest monitoring.
• Collaborate with CMC RA, DS, DP, Supply Chain and QA to reach goals.
• Coach and develop team to meet business goals.
• Establish and monitor operational metrics and trends.
• Track regulatory requirements and assess impact.

Skills

QC oversight

Regulatory knowledge

cGMP knowledge

Vendor management

Data review

Education

Bachelor’s degree in science

Master’s degree in science

PhD in science

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Associate Director QC will be responsible for oversight of the Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. Partner cross-functionally within PDM (drug substance, drug product, CMC Regulatory Affairs) and QA to manage method transfers, validations, and data oversight aligned with development and production timelines. Key responsibilities include vendor oversight, data review, external audits, and management of GMP-related exceptions (e.g., deviations, CAPAs, OOS/OOT, change controls).

Oversees designation of critical quality attributes, specification setting, and trending of method and product performance. Provides direction on method transfers and validations, ensuring compliance with regulatory standards and laboratory control requirements.

Responsibilities:

• Lead and/or coordinate QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, in-process control test, final release test, PAI readiness and inspection as needed.
• Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs).
• Manage quality events related to commercial QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.
• Author and/or review commercial QC related documents, including methods, protocols, reports and memos.
• Manage commercial phase reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.
• Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.
• Coach, mentor, and engage team to ensure business goals and development plans are met.
• Establish and monitor operational metrics to track performance and identify trends
• Monitor emerging regulatory requirements and assess organizational impact.
• Lead remediation efforts for identified gaps and drive continuous improvement initiatives.
• Excellent interpersonal, negotiation, and influencing skills with the ability to manage multiple priorities and lead change across all organizational levels.

Required Experience, Skills and Education:

• Bachelor’s degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages. Alternatively, a Master’s degree with 12+ years or a PhD with 10+ years is acceptable.
• Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.
• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
• Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.
• Strong problem-solving skills with sound technically driven decision-making ability.

Preferred Skills:

• Small molecule experience is required; biologics experience is highly preferred.
• Effective written and verbal communication skills and interpersonal skills.
• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Ability to multi-task and thrive in a fast-paced innovative environment.

#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.

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.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$186,000—$233,000 USD