BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors.
Requirements
- Advanced degree (Ph.D. or M.S.) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.
- 12+ years of progressive CMC experience in the biopharmaceutical industry, with a strong record of leadership across multiple technical functions.
- Proven experience leading cross-functional CMC teams from early development through late stage or commercial readiness.
- Deep understanding of regulatory expectations (FDA, EMA, ICH) and global submission requirements.
- Demonstrated ability to manage complex projects, multiple stakeholders, and external partners.
- Successful participation in IND and NDA/BLA submissions.
- Experience in a lean, cross-functional biotech environment balancing strategic and hands-on responsibilities.
Responsibilities
- Serve as the CMC representative on the cross-functional program team, accountable for CMC strategy, planning, and execution.
- Define and maintain a phase-appropriate CMC development plan that integrates process, analytical, and formulation strategies in alignment with clinical and regulatory milestones.
- Translate overall program objectives into actionable CMC development plans with clear deliverables, budgets, and timelines.
- Partner with the Head of CMC and functional leads to ensure alignment across programs and effective resource planning.
- Anticipate program risks, identify critical path activities, proactively developing contingency plans to ensure uninterrupted supply and regulatory compliance.
- Partner with functional leads of Process Chemistry, Analytical Development, and Formulation to ensure all technical workstreams are progressing according to plan, with clear deliverables and interdependencies.
- Provide scientific and technical guidance across process, analytical, and formulation disciplines, ensuring sound scientific rationale and regulatory compliance.
Other
- Excellent leadership, communication, and organizational skills with a proactive, solution-oriented mindset.
- Ability to work in a fast-paced, matrixed, and externalized environment.
- Lead the CMC team for assigned programs, fostering strong collaboration, accountability, and transparent communication.
- Provide mentorship and guidance to CMC functional team members and project managers.
- Actively contribute to CMC organizational strategy and continuous improvement initiatives.
