Job Description
About BBOTBBOT 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. For more information visit BBOTx.com.Who You AreWe are seeking a highly skilled Associate Director of Drug Product Development to lead formulation and process development activities for small molecules within our development pipeline. This role is critical to the advancement of programs from preclinical through commercial stages, with responsibility for the development and manufacturing of solid oral dosage forms, and other small molecule-based delivery systems.This position requires deep technical expertise in drug product development and pharmaceutics, with the ability to both engage collaboratively on cross-functional CMC teams and the skills necessary to manage external CDMOs across the globe.Key ResponsibilitiesLead the drug product development strategy for assigned small molecule programs, including solid oral dosage forms and other relevant formats.Design, review, and oversee formulation development, process development, and technology transfer activities.Develop phase-appropriate Clinical formulations with a view to overall program success on aggressive development timelines.Author, review, and approve key CMC documentation including development reports, batch records, and regulatory filings (INDs, IMPDs, NDAs, etc.).Manage outsourced development and manufacturing activities at CDMOs, ensuring technical rigor, compliance, and timeline adherence.Collaborate with internal CMC stakeholders including Process Chemistry, Analytical Chemistry, Reg CMC, and Supply Chain.Collaborate effectively as needed with ex-CMC partners, including Clin Ops, Clin Pharm, Global Reg, Quality, DMPK and Tox.Provide technical leadership on drug product troubleshooting, risk assessments, and change controls.Ensure activities are compliant with GMP, ICH guidelines, and global regulatory requirements.Travel as needed (up to 20%) to support critical manufacturing campaigns and attend company gatherings.