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 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.

Qualifications:

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

Equal Employment Opportunity:

The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Recruiters and Agencies:

BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHill employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

E-Verify:

BlossomHill Therapeutics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) to resolve the issue.

Recruitment Fraud Notice: BlossomHill Therapeutics will never send applicants a check, ask them to purchase equipment or gift cards, or request payment of any kind. Legitimate recruiting communications come only from an @bhtherapeutics.com email address, and all open positions can be verified through our official website. Sensitive onboarding information is collected only through BHT’s authorized onboarding process after an employment offer has been independently verified. If you receive suspicious recruiting communications claiming to represent BlossomHill Therapeutics, please contact Human Resources at our company.

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