Full-Time

Senior Scientist II

Analytical Development

Posted on 3/29/2024

Revolution Medicines

Revolution Medicines

201-500 employees

Specializes in precision oncology therapies

Biotechnology

Senior

San Carlos, CA, USA

Requirements
  • Master’s degree with 10+ years or PhD with 8+ years of relevant industrial experience in analytical development.
  • Extensive experience leading analytical activities independently in small molecule drug development.
  • Experience managing projects at CROs/CDMOs.
  • Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
  • Effective written and verbal communication skills and interpersonal skills.
  • Extensive knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.
  • Strong problem-solving skills with sound technically driven decision-making ability.
  • Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
  • Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
  • Ability to multi-task and thrive in a fast-paced innovative environment.
Responsibilities
  • Lead day-to-day operations to provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.
  • Contribute to analytical development strategy for multiple projects.
  • Demonstrate technical expertise on analytical technologies and act as a subject matter expert for Analytical Development function.
  • Select appropriate analytical techniques and coach and/or manage the contract lab counter parts to perform analytical method development/validation/transfer to support development and manufacturing of API and drug product.
  • Critically review data from contract partners (CDMOs and/or CTLs).
  • Manage stability testing programs assigned.
  • Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.
  • Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory 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

18%

1 year growth

48%

2 year growth

98%
INACTIVE