Associate Director, Drug Product, CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the strategy for drug product development pertaining to assigned small molecule programs, including solid oral dosage forms and other relevant formats.

• Design, review, and oversee formulation development, process development, and technology transfer initiatives.

• Create phase-appropriate clinical formulations aimed at ensuring overall program success within aggressive development timelines.

• Author, review, and validate essential CMC documentation such as development reports, batch records, and regulatory submissions (INDs, IMPDs, NDAs, etc.).

• Oversee outsourced development and manufacturing operations at CDMOs, ensuring technical rigor, compliance, and adherence to timelines.

• Collaborate with internal CMC stakeholders including Process Chemistry, Analytical Chemistry, Regulatory CMC, and Supply Chain.

• Work effectively as needed with external CMC partners, including Clinical Operations, Clinical Pharmacology, Global Regulatory, Quality, DMPK, and Toxicology.

• Provide technical leadership in drug product troubleshooting, risk assessments, and change controls.

• Ensure that all activities comply with GMP, ICH guidelines, and global regulatory standards.

• Travel as necessary (up to 20%) to support critical manufacturing campaigns and participate in company events.

⛳️ Requirements

• Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field with over 8 years of pertinent industry experience.

• M.S. degree with 12+ years of relevant industry experience.

• Proven experience in drug product development throughout clinical phases, focusing on pivotal development and readiness for commercialization.

• Experience in managing CDMOs and supervising external development and manufacturing processes.

• Hands-on expertise in drug product development, including formulation design and process optimization.

• Experience with scaling up and an understanding of its potential effects on CQAs.

• Outstanding problem-solving, organizational, and communication skills.

• Experience in authoring and reviewing regulatory submissions.

🏝️ Benefits

• Competitive salary, benefits, and meaningful equity participation in a company on the verge of entering the public market.

• Annual bonus.

• Stock-based long-term incentives.

• Medical, dental, and vision benefits.

• Retirement plan.

• Wellness stipend.

• Flexible time off.