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Senior Scientist II, Drug Product

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Industry: Biotechnology
  • Post Date: 02/12/2024
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Dr, Redwood City, California 94063, US

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.

Job Description

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.

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 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.      

The Opportunity:

  • 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.

  • Responsible for all solid form screening activities related to active pharmaceutical ingredients final form selection, polymorph, cocrystal and salt screening and crystallization method development for the compounds in development.

  • Be involved in crystallization and identifying / selecting CDMOs and oversee the development and manufacturing activities at CDMOs. Must have strong hands-on skills and experience to plan, design, implement and analyze experimentation to convert laboratory understanding to process knowledge of drug substances or drug products.

  • Responsible for conducting solution and solid-state pre-formulation studies for development candidates.

  • Collaborate with the Process Chemistry team to identify the final form.

  • Oversee the formulation development of compounds for discovery and lead optimization, including intravenous, oral, subcutaneous, and intraperitoneal delivery to support pharmacokinetic, efficacy, and toxicity studies.

  • Actively participate in pre-clinical and CMC teams to provide pharmaceutical development / developability input to influence lead identification and optimization.

  • 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.

  • Must have a thorough understanding on drug product manufacturing in a GMP environment, GMP compliance, process implementation and operation excellence.

  • Lead all the preformulation activities to support regulatory submissions.

  • Mentor and manage a team of scientists.

  • 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.

  • Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Analytical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.

Required Experience, Skills and Education:

  • Preferably a Ph.D. in pharmaceutical sciences, analytical chemistry, chemical engineering, physical organic chemistry, or related discipline.

  • 8+ years of relevant experience in pharmaceutical development.

  • Expertise in chemical analysis, material characterization and solid-state development.

  • Experience in small molecule drug preformulation characterization, formulation, and process development of oral and parenteral drug products.

  • Hands-on experiences in poorly water drug delivery technologies and enabling formulation development.

  • Experience in drug delivery technologies through various dosing routes of administration is a plus.

  • Knowledge of basic analytical skills required: HPLC, UV, LC/MS solid state characterization.

  • Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.

  • Working experience and knowledge of regulatory submission (IND, IMPD and / or NDA).

  • Excellent communication (both verbal and technical) and problem-solving skills.

  • Ability to multi-task and thrive in a fast-paced innovative environment.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $160,000 to $200,000. 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.

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