Manager, Analytical Development & QC

Revolution Medicines • Redwood City, CA

5h • Onsite

About The Position

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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for analytical data review, managing ADQC change control, managing reference materials, and raw materials at contract organization. The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.
Author and/or review QC related documents, including methods, protocols, reports and memos.
Coordinate and manage change controls.
Manage reference standards and reference materials including monitoring retest date, facilitating replenishment, qualification/requalification, and tracking inventory.
Perform data review in support of GMP activities for release, in-process, and stability testing as well as method validation and transfer.
Perform data entry & verification in reports, submissions, and other quality documentations.
Provide support to documentation preparation in quality system (e.g., Veeva).
Coordinate QC activities at CDMOs/CTLs.

Requirements

• BS or MS in Chemistry, Pharmaceutical Science or related discipline.
• 6+ years of relevant pharmaceutical or biotech industrial experience in analytical development/QC.
• Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, QbD, process validation, manufacture sampling and testing, stability study, method validation and transfer, 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
• 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.

Responsibilities

• Author and/or review QC related documents, including methods, protocols, reports and memos.
• Coordinate and manage change controls.
• Manage reference standards and reference materials including monitoring retest date, facilitating replenishment, qualification/requalification, and tracking inventory.
• Perform data review in support of GMP activities for release, in-process, and stability testing as well as method validation and transfer.
• Perform data entry & verification in reports, submissions, and other quality documentations.
• Provide support to documentation preparation in quality system (e.g., Veeva).
• Coordinate QC activities at CDMOs/CTLs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager