Director, Stability Management, Analytical Development and Quality Control
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 stability program lead, the position will be responsible for oversight and management of outsourced stability studies conducted. The director, stability is a self-motivated individual who works as a member of an integrated team contracting, designing, managing, and evaluating stability studies at contractors for both drug substance and drug product. This individual should have the breadth of experience required to manage stability studies in commercial, late and early clinical development stage. This individual should have broad knowledge of ICH and cGMP guidelines and the ability to contribute to global regulatory filings for stability.
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Develop and implement the strategic direction of stability programs in alignment with ICH guidelines and regulatory expectations.
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Oversee the design, execution, and management of stability studies (development, registration and commercial).
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Work cross functionally with CMC, quality, regulatory, clinical and related teams to achieve stability objectives.
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Compile stability study results, perform trend and statistical analyses, and prepare reports to support retest/shelf-life date extensions and storage condition recommendations.
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Partner with quality during stability quality events (QEs) or investigations and implementation of CAPAs at contractors.
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Serve as the primary point of contact for contract organization for all stability related activities.
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Oversee sample shipment if applicable, inventory tracking, and chain of custody for stability studies.
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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.
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Drive continuous improvement of stability management processes, including contract organization performance metrics.
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Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, sourcing and other related team to ensure alignment of stability design and achieve stability study objectives.
Required Skills, Experience and Education:
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PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years, or BS with 18+ years.
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10+ years in stability management or relevant experience within pharmaceutical or biotech industry.
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Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.).
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Extensive experience managing contract organization and working in a virtual development model.
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Excellent leadership, people/team management, project management, and cross-functional collaboration skills.
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Strong problem-solving skills with strategic and technically sound decision-making ability.
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Excellent written and verbal communication skills and interpersonal skills.
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Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.
Preferred Skills:
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Experience with small molecule oncology drug development.
#LI-Hybrid #LI-CT1
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.
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