Associate Director
Analytical Development & Quality Control
Posted on 3/25/2024
Revolution Medicines

201-500 employees

Develops targeted therapies for RAS-addicted cancers.
Company Overview
REVOLUTION Medicines stands out in the oncology field for its unique approach to drug discovery, leveraging insights from nature and evolution to develop targeted therapies for RAS-addicted cancers. The company's robust drug discovery and medicinal chemistry capabilities have resulted in a deep pipeline of RAS inhibitors, with their most advanced product, RMC-4630, currently in a multi-cohort Phase 1/2 clinical program. This focus on genetic drivers and adaptive resistance mechanisms in cancer, coupled with their commitment to exploring mechanism-based dosing paradigms and in-pathway combinations, positions REVOLUTION Medicines as a leader in precision oncology.
Biotechnology

Company Stage

N/A

Total Funding

$1.3B

Founded

2014

Headquarters

Redwood City, California

Growth & Insights
Headcount

6 month growth

19%

1 year growth

53%

2 year growth

92%
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Biology Lab & Research
Biology & Biotech
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.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.
  • Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
  • Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.
  • Strong problem-solving skills with sound technically driven decision-making ability.
Responsibilities
  • 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, including but not limited to commercial launch readiness, in-process control test and final release test.
  • 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.