Senior Director, CMC Drug Substance Development & Manufacturing

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. We are looking for a Senior Director, CMC Drug Substance Development & Manufacturing to join our team.

Requirements

• Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience, in a CMC development organization
• A minimum of 5+ years of direct people management and leadership experience
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
• Broad experience working with CDMOs and managing external development and manufacturing partners
• Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
• Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations
• Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications
• Thorough understanding of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substances
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews
• Effective written, oral communication and interpersonal skills
• Publications in peer reviewed journals and patent applications record

Benefits

• Competitive compensation and benefits package
• Equity
• Bonus
• Flexible and friendly work environment