Associate Director/Director, Drug Substance Development (CMC)

Boundless Bio (BBI) is a San Diego-based, next generation precision oncology company employing an exciting new area of cancer biology, extrachromosomal DNA (“ecDNA”), to revolutionize the way cancer is treated.  As an Associate Director/Director at Boundless Bio, you will play a significant role in helping us transform exciting ecDNA discoveries into the next revolution of cancer medicines.  You will have the opportunity to impact the discovery and development of transformational therapies in ecDNA driven cancers with high unmet medical needs.

We are seeking a highly motivated and experienced CMC (Chemistry, Manufacturing, and Controls) Drug Substance Specialist to join our dynamic CMC team. Reporting to the Head of CMC, the successful candidate will be responsible for leading all outsourced Drug Substance synthetic route scouting, process development and manufacturing activities, and CMC aspects for multiple BBI clinical candidates. Your expertise will be essential in ensuring the successful progression of drug candidates through various stages of development, from early research to commercialization.

Key Responsibilities:

Working in close collaboration with Drug Discovery, Non-Clinical, CMC, Clinical Operations, Finance, etc. in a highly energized biotech environment, responsibilities include but are not limited to: 

• Lead management of CDMOs for synthetic route development, process development and manufacturing of small molecule drug substance toxicology and cGMP supplies.
• Lead and contribute to the design and optimization of synthetic routes, chemical and manufacturing processes for regulatory materials, intermediates, drug substances, considering scalability, safety, quality, and cost-effectiveness.
• Develop and execute CMC strategies for early phase as well as late phase Drug Substance clinical supplies.
• Provide technical expertise in addressing challenges related to synthetic chemistry, process scale-up, impurity profiling, and purification.
• Perform thorough risk assessments and implement mitigation strategies to ensure robust and reliable drug substance manufacturing processes.
• Design and oversee experimental studies to validate and optimize manufacturing processes, ensuring adherence to regulatory guidelines and industry best practices.
• Collaborate with CMC and Quality teams to establish appropriate analytical methods and specifications for drug substance characterization and release testing, along with other quality documents such as change control, deviations, and CAPAs.
• Lead impurities origin, fate and effect studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process.
• Oversee pre-formulation activities such as solubility studies, polymorph and salt screening, lead form selection and optimization.
• Author and review technical documents, including development reports, batch records, specifications, and relevant CMC sections of regulatory submissions (IND, IMPD, etc.).
• Stay updated with the latest advancements in synthetic chemistry, process engineering, and regulatory requirements to drive continuous improvement in drug substance development and manufacturing strategies.
• Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality) to deliver BBI’s internal goals and objectives.

Education/Experience:

• PhD in Synthetic Organic Chemistry or related field with relevant drug substance development experience in the biopharmaceutical industry or MS with relevant experience.
• 10+ combined years of relevant experience in small molecule Drug Substance development and manufacturing, preferably in a small biotech setting with focus on early phase development.
• Deep understanding of synthetic organic chemistry principles, chemical process development, and scale-up of drug substance manufacturing processes.
• A strong understanding of cGMP and ICH regulations and an ability to apply them to drug substance development, validation and manufacturing is a must.
• Significant experience managing external partners and CDMOs for outsourced drug substance development and manufacturing activities.
• Strong technical understanding of pre-formulation studies, such as salt screening, polymorph screening and lead form selection.
• Prior experience authoring relevant sections of regulatory documents (IND/IMPD, NDA) and responses to regulatory agency questions globally.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Demonstrated ability to work independently and cross functionally in a highly collaborative matrixed environment.
• Proven problem-solving skills, collaborative nature, and adaptability across disciplines.
• Excellent verbal and written communication skills required.
• Ability to travel, as needed, approximately 20% of time.

The anticipated annual salary range for this position is $160,000 to $229,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. In addition to base salary, Boundless Bio employees are eligible for an annual bonus incentive and an equity stock option grant.  Boundless Bio offers a competitive benefits package including, medical, dental, vision, and life insurance for employees and their dependents.  We also offer a 401(k) plan with a matching contribution in addition to a flexible time off policy. 

Boundless Bio fosters an inclusive company culture that values diverse talent, backgrounds, and experiences. We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.