Associate Engineer, Drug Substance
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s 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:
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Work closely with DS, Analytical Development-QC and Quality teams to enable large-scale commercial manufacturing readiness, through process development and optimization studies conducted according to the principles of quality by design (QbD), establish control strategy and process characterization studies using tools such as design of experiment (DOE) studies.
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Support demonstration that large-scale manufacturing of DS can be conducted safely by proactively identifying risks and developing mitigation strategies (e.g. using reaction calorimetry and principles of FMEA and HAZOP).
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Support the transition of manufacturing of drug substance from clinical-stage through Process Performance Qualification (PPQ) to commercial-stage, and support commercial-stage activities (e.g. Continuous Performance Verification, CDMO relationship, etc.).
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Support technology transfer, process familiarization, and manufacturing at CDMOs, including PIP as needed.
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Review protocols, manufacturing batch records, development and campaign reports for clinical-scale and commercial-scale manufacturing.
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Utilize internal AI platform(s) to improve workflows and efficiency, for both internal team and cross-functional benefit.
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Communicate effectively within cross functional project teams.
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Travel to CDMO for the oversight of development activities and manufacturing (up to approximately 25%).
Required Experience, Skills and Education:
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BS chemical engineering or related discipline with 0-3 years industrial experience, in small-molecule chemical / drug substance process research and development .
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Familiar with synthetic organic chemistry.
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Familiar with review, update and creation of Process Flow Diagrams (PFDs) and Process & Instrumentation Diagrams (P&IDs).
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Familiar with writing, reviewing and updating Master and Executed Batch Records (MBRs and EBRs).
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Fluent in use of Microsoft Office products (Excel, Power Point, Word, Visio).
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Knowledge of current ICH guidelines, cGMP guidelines, and relevant industry practices.
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Strong problem solving skills with sound technically driven decision-making ability.
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Effective written and verbal communication skills and interpersonal skillsAn innovative team-player with high energy for our dynamic company environment.
Preferred Skills:
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Experience using AI platform(s) to improve workflows and efficiency, especially for Engineering calculations.
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Previous experience in chemical/small molecule manufacturing campaigns.
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Previous experience with Process Safety evaluations.
#LI-Hybrid #LI-CT1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range 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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Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
