Director, CMC Drug Substance

Olema Oncology is developing better medicines for breast cancer and beyond. The Director, CMC Drug Substance will provide technical leadership and hands-on execution to support late-stage development, technology transfer to CDMOs, and commercial readiness.

Requirements

• Ph.D. in Organic Chemistry or related discipline
• 10+ years of experience in small molecule CMC drug substance development and manufacturing
• Experience leading technology transfer, scale-up, and validation of API processes to GMP manufacturing sites
• Strong experience managing CDMOs, including vendor selection, technical oversight, and delivery of manufacturing campaigns
• Proven success authoring and reviewing CMC sections of INDs, IMPDs, and NDAs/MAAs
• Strong technical foundation in small molecule process development, manufacturing, and control strategy
• Deep understanding of cGMP requirements and global regulatory expectations
• Demonstrated ability to identify technical risks and apply risk-based decision-making
• Experience integrating process and manufacturing data to support process understanding, trend analysis, and continuous improvement
• Strong project management and communication skills

Benefits

• Competitive compensation and benefits package
• Flexible and friendly work environment
• Equal opportunity for all employees and applicants