Senior Manager, Manufacturing Engineering, Drug Substance jobs in United States
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Revolution Medicines · 1 day ago

Senior Manager, Manufacturing Engineering, Drug Substance

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The role involves supporting late-stage and commercial manufacturing of compounds, working closely with various teams to ensure quality and compliance throughout the manufacturing process.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

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

Qualification

Chemical EngineeringDrug Substance Process DevelopmentTechnical Report WritingMaster Batch RecordsCGMP GuidelinesMicrosoft Office SuiteProblem-Solving SkillsEffective CommunicationTeam Player

Required

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

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

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase