Full-Time
Vice President
Analytical Development & QC
Posted on 4/30/2024
Develops precision oncology therapies
Biotechnology
Senior
San Carlos, CA, USA
Requirements
- Minimum MSc degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
- 18 + years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership
- Extensive experience in late phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)
- Proven track record of strategic leadership and management with at least 10 years in a management role
- Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements
- Extensive working experience with management and oversight of the analytical activities at CDMOs and/or CTLs
- Strong problem-solving skills with strategic and sound technically driven decision-making ability
- Effective written and verbal communication skills and interpersonal skills
- Innovative team-player with high energy for our dynamic company environment
Responsibilities
- Lead analytical development and operations from early to late development through commercialization
- Be accountable for analytical related development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals and commercialization
- Author/review/approve the relevant CMC sections to enable global regulatory filings
- Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
- Serve as a project core team member and communicate CMC strategy and project status to the key stakeholder cross-functionally and assist in driving decision-making
- Collaborate with cross functional teams to ensure CMC and program goals are met
- Lead the efforts to assess / identify potential suppliers for analytical development and QC activities in support of drug substance and drug product development and manufacturing with adequate risk assessment
- Travel to CDMOs and/or CTLs for the vendor assessment and qualification, as well as analytical activities oversight as needed
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