Associate Director, Drug Product, CMC

Key Responsibilities

• 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.

Qualifications

• 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.

Preferred Qualifications

• 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.

Compensation

BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.