Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Sr Director, Commercial Manufacturing & Operations, you will be responsible for the execution of technical transfer, oversight of manufacturing activities, and creation of the commercial supply platform and strategy for the US launch of palazestrant in 2027.
Requirements
- BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with a minimum of 15 years of experience, in a CMC development and manufacturing organization
- Sense of urgency, ability to recognize time sensitivity, appetite to lead aggressive activity within the manufacturing function
- Flexible and adaptable style, achievement oriented by nature with a willingness and eagerness to take on challenges
- Visionary as well as tactile and concrete at an operational level.
- Demonstrated successful leadership in a pharmaceutical CMC drug substance and drug product development and manufacturing role
- Broad experience working with CDMOs and managing external development and manufacturing partners
- Expertise in 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
- Thorough understanding of global regulatory requirements for the manufacture, testing, and control of commercial drug substances
- Strong communication, negotiation, problem solving and decision-making skills at all levels of the organization, verbally and in writing
- Ability to work collaboratively to connect vision, strategy and goals and present plans, justifications and mitigation scenarios to executive management
- Effective written, oral communication and interpersonal skills
Benefits
- Competitive compensation package
- Benefits package