Manager, Drug Substance

BLOSSOMHILL THERAPEUTICS INC•San Diego, CA

9h•$147,900 - $184,065•Onsite

About The Position

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 [http://www.bhtherapeutics.com/].

Requirements

Ph.D. in Pharmaceutics, Chemical Engineering or a related discipline with at least 5 years of relevant industry drug discovery experience in biotech/pharmaceutical field
Extensive understanding of oral dosage development concepts from preformulation, -formulation to process and their applications in drug development settings including but not limited to excipient compatibility, prototype formulation, composition optimization, process development, clinical manufacturing, registration campaign and validation.
Working knowledge of ICH and health authority guidance
Significant leadership experience in a drug product setting under GMP, such as biotech or large pharma
Strong track record in study protocol writing, data analysis, and report generation for supporting global registration
Experienced in managing external drug product CROs support development programs
Strong communication and people management skills, including demonstrated ability to navigate a matrixed organization, communicate chemistry strategies to functional areas and executive team
Ability to successfully handle multiple tasks and goals with time constraints
Ability to work at both a strategic and tactical, hands-on level

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 and process.
Work with research and development functions to advance the identified drug candidates from pre-clinical stage to clinical stage through IND enabling activities.
Perform pre-formulation studies, initiate FIH drug product design and subsequent optimization work which needs collaboration with research and development functions.
Leverage knowledge and experience in dosage form development to evaluate CMOs, establish service contracts, and tech transfer to the selected CMOs.
Manage manufacture of clinical batches and registration batches (including bulk and packaged products) at CMOs per agreed timeline to ensure timely supply for clinical trials.
Perform phase appropriate risk assessment for formulation and process; Perform batch review and data analysis, and complete reports through collaboration with CMOs.
Support requests from regulatory affairs, product quality, supply chain and other functions as the subject matter expert. Author CMC drug product sections for IND/IMPD/NDA/MAA application.
Commit to Company’s philosophy of Innovation and Best-in-Class, comply with Company’s policies and SOPs, and adhere to trainings required by Company.