Location: all cities,CA, USA
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 RASCompanion 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 critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for pre-formulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
Responsibilities:
* Lead and/or support activities for pharmaceutical profiling, phase-appropriate formulation development, and drug product manufacturing of the new chemical entities of RevMed during preclinical assessment and throughout clinical development phases.
* Lead/support pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization and process validation activities related to solid oral dosage and parenteral drug products.
* Responsible for the development of strategies, overseeing the execution of technical activities associated with product development and manufacturing in support of clinical development, regulatory filings (IND/NDA/MAA), and product approvals and commercialization.
* Oversee formulation development of compounds for discovery and lead optimization, including intravenous, oral, subcutaneous, and intraperitoneal delivery to support pharmacokinetic, efficacy, and toxicity studies.
* Design and oversee execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.
* Design and execute studies either in-house and/or through CROs/CDMOs to effectively screen candidates, and better understand delivery barriers of potential leads pertaining to the intended dosing route, and to enable candidate progression.
* Actively participate in pre-clinical and CMC teams to provide pharmaceutical development/developability input to influence lead identification and optimization.
* Travel to CDMOs for vendor assessment and qualification, as well as manufacturing oversight as needed.
Required Experience, Skills, and Education:
* Preferably a PhD in pharmaceutical sciences, chemical engineering, physical organic chemistry, or related discipline.
* 8+ years of relevant experience in pharmaceutical development.
* Experience in preformulation characterization, formulation, and process development of oral and parenteral drug products.
* Thorough understanding and working experience of pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements.
* Experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China
* Strong critical thinking skills with strategic and sound technically driven decision-making ability.
* Must have a thorough understanding of drug product manufacturing in a GMP environment, GMP compliance, process implementation and operation excellence.
* Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
* Excellent communication (both verbal and technical) and critical thinking skills.
* Ability to multi-task and thrive in a fast-paced innovative environment.
Preferred Skills:
* Experience in late-stage development, scale-up and product launch.
* Direct experience in drug delivery technologies through various dosing routes of administration is a plus.
The base salary range for this full-time position is $160,000 to $200,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. 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 our CCPA Notice and Privacy Policy. For additional information, please contact ...@revmed.com.
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