Senior Engineer I, Drug Substance

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.

The Opportunity:

Playing an important role as Engineering support within the Drug Substance (DS) function, and working closely with process chemists, the successful candidate will be responsible for supporting early-stage process development and late-stage process development/process validation as well as supporting preparation for commercial manufacturing of Revolution Medicines’ compounds. Responsibilities will also include tech-transfer support across a variety of CDMOs, making starting materials, intermediates and DS for Revolution Medicines’ compounds.

Responsibilities:

• 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.

• Support development of robust processes for commercial manufacturing of drug substance, intermediates and/or starting materials using the most modern technologies, including continuous processing, automated reaction screening, PAT, and modeling and simulation.

• 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).

• 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.).

• Evaluate and communicate issues which may impact quality, compliance, timelines, budget and business relationship.

• Support technology transfer, process familiarization, and manufacturing at CDMOs, including PIP as needed.

• Write and review protocols, manufacturing batch records, development and campaign reports for clinical-scale and commercial-scale manufacturing.

• Support authoring of regulatory submissions and responses to regulatory authorities.

• Communicate effectively within cross functional project teams.

• Travel to CDMO for the oversight of development activities and manufacturing (up to approximately 25%).

Required Skills, Experience, and Education:

• BS chemical engineering or related discipline with a minimum of 5 years industrial experience, in small-molecule chemical / drug substance process research and development.

• Proficiency in synthetic organic chemistry.

• In-depth knowledge of principles of QbD, employing techniques such as DoE, OFAT and efficient reaction design.

• Fluent in review, update and creation of Process Flow Diagrams (PFDs) and Process & Instrumentation Diagrams (P&IDs).

• Fluent in writing, reviewing and updating Master and Executed Batch Records (MBRs and EBRs).

• Fluent in use of Microsoft Office products (Excel, Power Point, Word, Visio).

• Knowledge of current ICH guidelines, cGMP guidelines, and relevant industry practices.

• Strong problem solving skills with sound technically driven decision-making ability.

• Effective written and verbal communication skills and interpersonal skills.

• An innovative team-player with high energy for our dynamic company environment.

Preferred Skills:

• In-depth knowledge of operational design, process modeling, process equipment selection and scale-up methodologies.

• Experience in use of modern technologies such as continuous/flow manufacturing, automated reaction screening and PAT.

• Training and awareness in Chemical Process Safety reviews and measurement techniques/equipment.

The base salary range for this full-time position is $140,000 to $180,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in