Director, Quality Control

Revolution Medicines; Redwood City (CA); On-site; USD 204,000 - 255,000; Full time

Job summary

A leading clinical-stage precision oncology company is seeking a Quality Control Manager to oversee QC activities from process validation to commercial launch readiness. The role involves strategic ownership of QC activities and collaboration with cross-functional teams. Ideal candidates will have extensive experience in analytical development and a solid understanding of regulatory requirements.

Benefits

Competitive cash compensation

Robust equity awards

Strong benefits

Learning and development opportunities

Qualifications

• 10+ years of relevant industrial experience in analytical development/QC.
• Solid understanding of compliance and regulatory requirements.

Responsibilities

• Oversee QC activities from process validation to commercial launch readiness.
• Manage outsourced commercial QC activities at CDMOs and CTLs.

Skills

Communication

Problem-Solving

Interpersonal Skills

Analytical Development

Education

BS or MS in Chemistry

Pharmaceutical Science

Tools

Chromatography

Job description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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 project leading role and Subject Matter Expert (SME) of late phase and commercial Quality Control within the CMC function, this position will be responsible for overseeing a team and individually contributing to the management of QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP) and final product (FP) manufacturing. The candidate will also be responsible for post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

1. Provide strategic and tactical ownership for QC activities of late phase and commercial programs, including but not limited to commercial launch readiness including establishment of CDMO and/or CTL.

2. End to end process management for analytical purposes in support of manufacturing operations for release of commercial product.

3. Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs) for release and stability purposes.

4. 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.

5. Support regulatory submissions and commercial life cycle management to maintain operational uniformity.

6. Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to achieve project goals per timelines.

Required Skills, Experience and Education:

• BS or MS in Chemistry, Pharmaceutical Science or related discipline.

• 10+ years of relevant industrial experience in analytical development/QC.

• Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.

• Effective written and verbal communication skills and interpersonal skills.

• 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

• Excellent 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.

Preferred Skills:

• Experience in solid oral dosage including dissolution testing.

• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.

• Commercial QC experience.

• Chromatographic experience in development, optimization, and troubleshooting.

The base salary range for this full-time position is $204,000 to $255,000 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.

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 ourCCPA NoticeandPrivacy Policy.For additional information, please [e-mail].

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