Senior Scientist, Analytical Development (Hybrid)

Revolution Medicines, Inc.; Redwood City (CA); Hybrid; USD 170,000 - 212,000; Full time

Benefits offered by this job

Base salary and comprehensive benefits

Job summary

Revolution Medicines, Inc. in Redwood City, CA is seeking a Senior Scientist II to lead day-to-day analytical development activities supporting API process R&D, formulation development and manufacturing.

You will contribute to strategy and act as SME for Analytical Development in cross-functional teams. The role requires extensive industry experience in analytical development for small molecules, CRO/CDMO management, and regulatory submissions knowledge, with strong communication and

Qualifications

• 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).
• Excellent 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.

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 counterparts 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.

Skills

Analytical development

Method development

ICH/GMP knowledge

Project leadership

Regulatory communication

Cross-functional collaboration

Education

PhD in analytical chemistry

MS in analytical chemistry

Job description

Revolution Medicines, Inc. in Redwood City, CA is seeking a Senior Scientist II to lead day-to-day analytical development activities supporting API process R&D, formulation development and manufacturing.

You will contribute to strategy and act as SME for Analytical Development in cross-functional teams. The role requires extensive industry experience in analytical development for small molecules, CRO/CDMO management, and regulatory submissions knowledge, with strong communication and