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Full-Time

Associate Director

Quality Control

Confirmed live in the last 24 hours

Revolution Medicines

Revolution Medicines

201-500 employees

Specializes in precision oncology therapies

Hardware
Biotechnology
Healthcare

Compensation Overview

$160k - $200kAnnually

+ Equity Awards

Expert

San Carlos, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • BS or MS in Chemistry, Pharmaceutical Science or related discipline
  • 10+ years of relevant industrial experience in analytical development/QC with 5+ years Commercial QC experience
  • Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.)
  • Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.)
  • Extensive knowledge and understanding of cGMP guidelines and practices
  • Strong problem-solving skills with sound technically driven decision-making ability
Responsibilities
  • Manage QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP) and final product (FP) manufacturing
  • Provide supports to stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed
  • Lead and/or coordinate QC activities of late phase and commercial programs
  • Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs)
  • Manage quality events related to commercial QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs
  • Author and/or review commercial QC related documents, including methods, protocols, reports and memos
  • Manage commercial phase reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory
  • Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals

### Welcome to Revolution Medicines, crafting the future of oncology with precision. Our focus is on advancing RAS(ON) inhibitors and RAS Companion inhibitors, marked by the remarkable journey of our lead product, RMC-4630, through its clinical phases. Supported by a team of passionate oncology experts, we are steadfast in our mission to develop treatments that precisely target oncogenic mutations, promising a brighter, healthier tomorrow for patients everywhere. ###

Company Stage

IPO

Total Funding

$1.3B

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

17%

1 year growth

46%

2 year growth

111%