Lead Scientific Strategy Across the Drug Development Lifecycle
As Director, Drug Product Development, you will guide the technical direction of pharmaceutical development programs, ensuring robust formulation design and scalable manufacturing processes for small molecule candidates. Your expertise will span from early preformulation through commercialization, with responsibility for establishing product and process specifications, including equipment, materials, testing methods, and packaging requirements.
Lead Cross-Functional Teams and External Partners
- Direct cross-functional CMC teams to deliver development milestones on time and within budget.
- Oversee technical activities at contract development and manufacturing organizations (CDMOs), including work plan development, performance management, and technical transfer.
- Support vendor selection and due diligence for development and manufacturing partners.
Regulatory and Compliance Leadership
Author and review CMC sections of regulatory submissions for global health authorities. Apply up-to-date knowledge of cGMP, FDA, and EU regulations to ensure compliance in development, process validation, and quality systems. Support regulatory inspections as needed, including defending development strategies and investigation outcomes.
Innovation and Operational Excellence
Develop intellectual property around new drug products and formulations. Identify opportunities to improve development workflows using industry best practices. Mentor team members, review technical documentation, and contribute to product development strategies across functions.
Qualifications
Advanced degree or equivalent experience in pharmaceutical sciences or a related field. Minimum of 10–15 years in pharmaceutical development with direct experience in formulation, process development, tech transfer, and regulatory CMC submissions. Demonstrated leadership in managing technical programs, solving complex development challenges, and communicating effectively with senior stakeholders. Willingness to travel as needed for business purposes.
