Senior Process Engineer I

1 week ago

Redwood City, California, United States REVOLUTION Medicines Full time

Senior Process Engineer I

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.

  • 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 preformulation, 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 Skills, Experience and Education:
  • 5+ 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.
  • Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China.
  • Strong problem-solving skills with strategic and sound technically driven decision-making ability.
  • Hands-on experience in drug delivery technologies through various dosing routes of administration is a plus.
  • Must have a thorough understanding on 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.
  • Experience in late-stage development, scale-up and product launch is a plus.
  • Excellent communication (both verbal and technical) and problem-solving skills.
  • Ability to multi-task and thrive in a fast-paced innovative environment.
Preferred Skills:
  • Preferably a PhD in pharmaceutical sciences, chemical engineering, physical organic chemistry, or related discipline.
The expected salary range for this role is $135,000 to $175,000. 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

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