About the job
At Olema Oncology, we are committed to advancing innovative therapies for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a leading-edge complete estrogen receptor antagonist (CERAN) currently under development for metastatic breast cancer. With the potential to be a blockbuster treatment both as a monotherapy and in combination therapies for ER+/HER2- metastatic breast cancer, our work is at the forefront of oncology. Additionally, our next candidate, OP-3136, is a promising KAT6 inhibitor with the potential to set new standards in treatment efficacy.
Our culture thrives on collaboration, support, and motivation, which drive our scientific breakthroughs. At Olema, we prioritize our people, ensuring that our work is impactful not just for our patients, but also for your career and the future of cancer treatment. If you are eager to be part of a transformative journey, join us in making a significant difference.
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About the Role >>> Associate Director, Analytical Development
In the role of Associate Director of Analytical Development, you will report to the Senior Director of Analytical Chemistry. You will play a vital role in advancing both early and late-stage therapeutic molecules by providing phase-appropriate analytical methods, validation, and tech transfers. Your collaboration with cross-functional teams will support process development, formulations, CMC, and quality assurance initiatives. This position demands strong teamwork, collaboration skills, and an ability to thrive in a dynamic biotech environment.
This role is located in our San Francisco office and will require 10-15% travel.
Your responsibilities will include:
- Developing, qualifying, and validating analytical methods for starting materials, in-process controls, process intermediates, drug substances, and drug products.
- Conducting analytical technical reviews of method validation/qualification protocols, data, and reports generated at CDMOs for drug substances and drug products.
- Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products.
- Managing stability programs, monitoring/trending stability data, and determining retest periods or shelf lives for drug substances or drug products.
- Providing technical input and addressing analytical and quality control issues, deviations, and discrepancies.

