Senior Scientist II, Analytical Development
Revolution Medicines
Revolution Medicines seeks a Senior Scientist II in Analytical Development to lead analytical support for API and drug product development and manufacturing. The role involves managing analytical strategies, overseeing contract laboratory partners, and ensuring regulatory compliance across multiple oncology projects.
Responsibilities
- Lead daily analytical support for API process R&D, formulation development, and drug product manufacturing
- Develop and execute analytical strategies across multiple projects
- Select analytical techniques and manage contract laboratory partners on method development and validation
- Critically review analytical data from CDMOs and contract testing labs
- Manage stability testing programs and prepare regulatory submission documents
Requirements
- Master's degree with 10+ years or PhD with 8+ years in analytical development
- Extensive independent leadership of analytical activities in small molecule drug development
- Experience managing projects at CROs or CDMOs
- Knowledge of regulatory submissions (IND, IMPD, NDA)
- Expertise in ICH and GMP guidelines and industry practices
- Strong problem-solving and critical thinking with independent decision-making ability
Vacancy posted 15 days ago
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