Associate Director, Drug Product, CMC

🕒 April 7

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Lead 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.

🎯 Requirements

• At least 5 years of lab-based experience specifically in small molecule drug product development. • Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 8+ years of relevant industry experience OR M.S. with 12+ years of relevant industry experience. • Specific experience in Pivotal drug product development, registration batches, validation or commercial. • Experience with Quality by Design (QbD) and Design of Experiments (DoE) for selection and optimization of drug product. • Experience in developing BCS Class II/IV drugs. • Experience directly managing CDMOs and overseeing external development and manufacturing. • Tech transfer and scale up experience of drug product manufacturing processes.

🏖️ Benefits

• annual bonus • stock-based long-term incentives • medical, dental, and vision benefits • retirement • wellness stipend • flexible time off