Senior Manager, Manufacturing Engineering, Drug Substance bei Revolution Medicines

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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Playing an important role for Manufacturing Engineering support within the Drug Substance (DS) function, reporting to the Principal Engineer, and working closely with process chemists, engineers, and business operations, the successful candidate will be responsible for supporting late-stage and commercial manufacturing of Revolution Medicines’ compounds across a variety of CDMOs, including RSM synthesis. Responsibilities may also include back-up support for early and late-stage production of Revolution Medicines’ compounds.

Responsibilities:

• Work closely with DS, Analytical Development-QC, Supply Chain and Quality teams to prepare for large-scale commercial manufacturing campaigns, including RFP and tech package preparation and support for RSMs, intermediates and API.

• 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.).

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

• Support technology transfer and commercial manufacturing campaigns at CDMOs, as part of the DS team, including PIP support as needed.

• Support writing and review of protocols, manufacturing batch records, development and campaign reports for late-stage and commercial-scale manufacturing.

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

• Communicate effectively within cross-functional project teams.

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

• Support clinical-stage process development/production campaigns, as needed.

Required Skills, Experience and Education:

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

• Experience with managing production/manufacturing campaigns.

• Fluent in writing technical reports, tech packages and request for proposals; evaluating vendor proposals and performance.

• 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:

• Preferred experience managing late-stage/commercial manufacturing at CDMOs.

• Preferred experience transitioning drug substance from clinical stage production to late stage and commercial manufacturing.

• Preferred experience managing the hiring, career development, and mentorship of a team. #LI-Hybrid #LI-CT1