Senior Manager, Analytical Development & Quality Control
Senior Manager, Analytical Development & Quality Control
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$ 158000 - 198000
1 Vacancy
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 companys 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 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 managing QC activities from process validation to commercial manufacture of drug substance (DS) drug product (DP) and final product (FP). The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE PAS etc.
Provide support for stability program management quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.
Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs) including but not limited to in-process control test final release test and stability study.
Manage quality events related to 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 QC related documents including methods protocols reports and memos.
Manage reference standards and 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.
Required Skills Experience and Education:
BS or MS in Chemistry Pharmaceutical Science or related discipline.
6 years of relevant 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.
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.
Commercial QC experience is preferred.
Work experience and knowledge of global regulatory submissions (IND IMPD NDA and MAA etc.) is preferred.
Chromatographic experience in development optimization and troubleshooting.
The base salary range for this full-time position is $158000 to $198000 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 additional information please contact.
#LI-Hybrid #LI-CT1
Required Experience:
Senior Manager
Employment Type
Full Time
