Manager, Drug Product

About BlossomHill Therapeutics: BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. For more information visit BlossomHill Therapeutics. Job Summary: The Manager, Drug Product, will work closely with the CMC team to design formulations and manufacturing processes suitable for early clinical trials leading to commercial launch. This candidate will then implement such formulations/processes at various CROs, perform data analysis, and compile reports in collaboration with these respective CROs. Additional responsibilities include managing such CROs to produce bulk and packaged clinical supplies to enable clinical studies. The Manager should have strong capabilities and knowledgebase for leading designs of compatibility, prototype compositions, manufacturing unit operations, scale-up, technology transfer, and global registration of solid and liquid dosage forms. The Manager must be excellent at multi-tasking and have the courage to push the boundaries and assume a broad array of responsibilities. The Manager should be a great team player, exemplary communicator, and thrive in a fast-paced/results-oriented environment managing multiple projects. This individual will be responsible for design, development, and manufacture of oral drug products (solids and liquids) from early clinical phases to enabling commercial launch. The Manager will design robust formulations and processes, implement effective formulation and process development at CMO’s, manage timely production of clinical trial materials at CMO’s, and assume subject matter expertise in supporting regulatory filing, product quality, supply chain etc. The Manager, Drug Product, should have comprehensive knowledge and technical skills in strategizing development of phase-appropriate formulations and processes across product life cycle, and have demonstrated proficiency in handling multiple projects, collaboration within CMC team, communicating across multidisciplinary functions, and managing CMO’s to deliver results under accelerated timeline. The position is an onsite role, based in BlossomHill's San Diego office. Key Responsibilities: Collaborate within CMC team and across multidisciplinary functions seamlessly to progress the novel small molecule drug candidates according to Company’s goals and timelines. Take the responsibility for the design and optimization of formulation studies for novel small molecules, and work with other research and development groups to progress the projects under the Company’s goals and priority. Have deep and cutting-edge knowledge in dosage form design principles to facilitate the project progression effectively via internal and external CMO/CRO efforts. Responsible for the designs, optimization, and execution of clinical/registration batch manufacturing at CROs selected by BlossomHill Therapeutics Work with external CROs and integrate with internal efforts to advance drug candidates from pre-clinical to clinical to commercial stages. Independently perform risk analysis for composition an…

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