Full-Time
Associate Director
Confirmed live in the last 24 hours
Develops precision oncology therapies
Biotechnology
Compensation Overview
$160,000 - $200,000Annually
+ Equity
Senior, Expert
San Carlos, CA, USA
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.
Revolution Medicines specializes in developing precision oncology therapies, particularly RAS(ON) inhibitors and RAS Companion inhibitors, with their lead product candidate, RMC-4630, currently in a Phase 1/2 clinical program targeting specific oncogenic mutations in various tumor types. The company's main focus is on developing these therapies to target specific oncogenic mutations in different tumor types, utilizing precision oncology technologies.
Company Stage
IPO
Total Funding
$1.3B
Headquarters
Redwood City, California
Founded
2014
Growth & Insights
Headcount