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 companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys 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.

• Develop and implement the strategic direction of stability programs in alignment with ICH guidelines and regulatory expectations.

• Oversee the design execution and management of stability studies (development registration and commercial).

• 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 contractors.

• Serve as the primary point of contact for contract organization for all stability related activities.

• Oversee sample shipment if applicable 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.

• Drive continuous improvement of stability management processes including contract organization performance metrics.

• 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:

• PhD in Chemistry Pharmaceutical Sciences or related discipline with 12 years of industry experience; or MS with 15 years or BS with 18 years.

• 10 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.

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