Senior Manager, Stability Management, Analytical Development and Quality
Redwood City, California, United States · Hybrid
$164k–$205k/yr
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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 dive…
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Senior Manager, Stability Management, Analytical Development and Quality
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$164k–$205k/yr
Full-time
bachelor degree, postgraduate degree
Cash Compensation, Equity Awards, Learning And Development Opportunities
Posted 32d ago
~40 hrs/week
Responsibilities
Act as the subject matter expert for stability management, overseeing outsourced stability studies from design through evaluation. Coordinate with cross-functional teams to author regulatory documentation and ensure the accuracy of stability data for clinical and commercial filings.
Requirements
Requires a PhD with 8+ years, MS with 10+ years, or BS with 12+ years of industry experience, including 6+ years specifically in stability management. Must possess strong knowledge of GMP, ICH guidelines, and experience managing contract research organizations.
Full 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:
Playing a critical role as the subject matter expert (SME) on stability management, the position will be responsible for management of outsourced stability studies. The Sr. Manager, stability is a self-motivated individual who works as a member of an integrated team from design, management, and evaluation stability studies outsourced to contract organization. This individual should have the breadth of experience and knowledge required to support commercial, late and early clinical development stage. This individual should have good understanding of ICH and cGMP guidelines and the ability to contribute to global regulatory filings for stability.
Coordinate stability activities, including but not limited to monitor schedule, data entry, review and presentations/reports.
Author and / or review stability related documents, including protocol, report, and memos.
Work cross functionally with CMC, quality, regulatory, clinical and related teams to achieve stability objectives.
Compile stability study results, perform trend and statistical analyses, and prepare reports to support retest/shelf-life date extensions and storage condition recommendations.
Partner with quality during stability quality events (QEs) or investigations and implementation of CAPAs at contract organization.
Manage sample shipment, inventory tracking, and chain of custody for stability studies.
Support, author CMC stability documentation for IND, NDA, AR and IMPD filings, covering all phases of clinical development and commercial activities by ensure completeness and accuracy of stability data.
Required Skills, Experience and Education:
PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 8+ years of industry experience; or MS with 10+ years, or BS with 12+ years.
6+ years in stability management or relevant experience within pharmaceutical or biotech industry.
Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.).
Extensive experience managing contract organization and working in a virtual development model.
Excellent leadership, people/team management, project management, and cross-functional collaboration skills.
Strong problem-solving skills with strategic and technically sound decision-making ability.
Excellent written and verbal communication skills and interpersonal skills.
Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.
Preferred Skills:
Experience with small molecule oncology drug development.
#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 [email protected].
Base Pay Salary Range
$164,000—$205,000 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.
Revolution Medicine enables physicians to integrate personalized medicine into their practices in order to more effectively treat patients.
Our genes play an important role in determining how we respond to about 75% of prescription drugs. Scientific research has demonstrated which genes predict these responses. According to the American Medical Association (AMA), 98% of physicians agree that knowing a patient’s genetic profile would help in prescribing medications. Yet, 90% of physicians do not feel they are adequately informed about how to apply genetic testing to treatment decisions.
Our mission is to improve the quality of patient care by helping doctors determine optimal treatment strategies and more accurately predict treatment responses. Revolution Medicine has developed ScriptMatch, an analytical process that enables physicians to easily incorporate genetic testing into their practices.
Our company solves a major issue in the clinical market and addresses an emerging trend in patient-driven healthcare: having clinical results that become part of the medical record and applicable to future treatments.
How much do Management & Leadership jobs in Redwood City, CA pay?
Based on 356 listings with disclosed salaries, most management & leadership jobs in Redwood City, CA pay between $102k–$260k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Redwood City, CA right now?
There are currently 419 open management & leadership positions in Redwood City, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Redwood City, CA?
Companies currently hiring include Revolution Medicine, Delinea, Corcept Therapeutics, C3 AI, Box, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Redwood City, CA?
Yes — 223 of the 419 open management & leadership positions offer remote or hybrid work (44 remote, 179 hybrid).
How do I apply for Management & Leadership jobs in Redwood City, CA?
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