Revolution Medicines, Inc

Playing a critical role as the subject matter expert (SME) and technical lead of Drug Product within PDM function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.. Responsible for form selection, formulation, and process development, scale-up, process optimization, clinical manufacturing and technology transfer of drug product from preclinical lead optimization stage through product launch.. Execute preformulation related activities to define the physico-chemical properties of the active ingredient to define solubility, pKa, physical form screening, chemical stability, physical stability, solid state characterization (including SSNMR, DSC, TGA, PXRD, Raman, DVS, PLM).. Oversee the formulation and process development, technology transfer, process scale up and manufacturing activities at CMO.. Prepare, review, and/or approve manufacturing batch records, development and campaign reports, CMC regulatory submission document, study protocols and reports.

scientist ii

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 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.
<h3>The Opportunity</h3>
Playing a critical role as the subject matter expert (SME) and technical lead of Drug Product within PDM function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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Lead or support drug product development activities to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization.
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Responsible for form selection, formulation, and process development, scale-up, process optimization, clinical manufacturing and technology transfer of drug product from preclinical lead optimization stage through product launch.
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Perform formulation of compounds for discovery and lead optimization, including intravenous, oral, subcutaneous, and intraperitoneal delivery to support pharmacokinetic, efficacy, and toxicity studies.
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Plan and manage GMP manufacturing of drug products to support clinical studies, primary stability and process validation.
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Execute preformulation related activities to define the physico-chemical properties of the active ingredient to define solubility, pKa, physical form screening, chemical stability, physical stability, solid state characterization (including SSNMR, DSC, TGA, PXRD, Raman, DVS, PLM).
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Oversee the formulation and process development, technology transfer, process scale up and manufacturing activities at CMO.
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Prepare, review, and/or approve manufacturing batch records, development and campaign reports, CMC regulatory submission document, study protocols and reports.
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Design and manage process development studies using quality by design approach. Study and identify critical quality attributes and critical process parameters for drug product. Explore and establish the proven acceptable range and control strategy for drug product manufacturing.
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Collaborate with cross functional teams including but not limited to Clinical Supply, Quality Assurance, Analytical Development, Process R&D, Project Management, Regulatory and Research teams to timely achieve project goals.
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Design and execute studies in-house and/or through CROs/CDMOs to effectively screen candidates, to better understand delivery barriers of potential leads pertaining to the intended dosing route, and to enable candidate progression.
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Participate in pre-clinical team and CMC team to provide pharmaceutical development / developability input to influence lead identification and optimization.
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Travel to CRO/CDMO for the oversight of development and manufacturing activities (up to 20%).
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Required Experience, Skills and Education:
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Preferably a graduate degree in pharmaceutical sciences, chemical engineering, physical organic chemistry or related discipline.
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Ph.D. with 5 years of relevant experience or Master with 15+ years of experience in pharmaceutical development.
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Experience in formulation and process development, DOE study, technology transfer, process scale-up, GMP manufacturing, packaging, and process validation of oral and /or parenteral drug products.
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Hands-on experience in poorly water drug delivery technologies and enabling formulation development.
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Knowledge of basic analytical skills required: HPLC, UV, solid state characterization, etc.
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Knowledge and understanding of current ICH guidelines, GMP regulations, and related industry practices.
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Working experience and knowledge of regulatory submission (IND, IMPD and / or NDA).
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Excellent communication (both verbal and technical) and problem-solving skills.
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Ability to multi-task and thrive in a fast-paced innovative environment.
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The expected salary range for this role is $120,000 to $158,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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 privacy@revmed.com.

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