About the job
At Olema Oncology, we are committed to revolutionizing the treatment landscape for breast cancer and other conditions. Our flagship program, palazestrant (OP-1250), represents a groundbreaking complete estrogen receptor antagonist (CERAN) currently under development for metastatic breast cancer, showing exceptional promise as both a standalone therapy and in combination for ER+/HER2- metastatic breast cancer. Additionally, our next candidate, OP-3136, is a leading KAT6 inhibitor poised to set new standards in treatment efficacy.
We foster an environment of innovation, encouragement, and mutual challenge, knowing that prioritizing our people leads to unparalleled outcomes. If you are eager to be a part of a transformative journey, let's create meaningful change together for our patients, your career, and the future.
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Position: Associate Director of Formulation Development
In your role as Associate Director of Formulation Development, you will report to the Senior Director of Drug Product. You will spearhead pre-formulation and formulation development, tech transfer, scale-up, and manufacturing initiatives at Olema’s Contract Manufacturing Organizations (CMOs) or Contract Development and Manufacturing Organizations (CDMO). This pivotal role entails providing scientific insights into solid oral dosage formulation development, managing early to late-stage process development, overseeing GMP drug product manufacture at contract facilities, authoring global regulatory submissions (INDs, IMPDs, NDAs, etc.), as well as ensuring the validation of packaging, shipping, and transportation in preparation for commercial launch. You will work collaboratively with cross-functional teams and other CMC functions in a dynamic, high-growth setting to advance Olema’s small molecules from discovery to commercialization.
This position is based in our Dublin, Ireland office and will require 25-30% travel.
Your responsibilities will include:
- Leading preclinical and early clinical phase formulation development efforts at CMOs and overseeing tech transfer to GMP vendors for clinical drug product manufacture and scale-up.
- Designing and supervising formulation development activities, ensuring alignment with regulatory standards and timelines.
