Associate Director, Drug Product Development

Job Functions/Responsibilities

• Lead drug product formulation and process development, scale-up, technology transfer, process characterization, validation, and lifecycle management activities.
• Develop phase-appropriate strategies for clinical and commercial programs, balancing scientific rigor, regulatory expectations, technical risk, timelines, and cost.
• Interpret manufacturing, analytical, and stability data to identify trends, troubleshoot issues, and guide appropriate changes to formulations, processes, and control strategies.
• Provide technical leadership for GMP manufacturing activities, investigations, deviations, process optimization, and continuous improvement.
• Lead technical oversight of CDMOs, including development, manufacturing, technology transfer, validation, investigations, and performance management.
• Persistently partner closely with Quality, Supply Chain and Regulatory CMC to develop scientifically sound and pragmatic approaches to product development, manufacturing, and regulatory strategy.
• Communicate technical risks, recommendations, and business implications effectively to cross-functional teams and senior leadership.

Qualifications

• Education / Experience: Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline; equivalent relevant experience will be considered. 10+ years of pharmaceutical/biotechnology industry experience with significant experience in drug product development and GMP manufacturing.
• Demonstrated experience with formulation and process development, scale-up, technology transfer, and process validation.
• Experience supporting both clinical-stage development and commercial manufacturing preferred.
• Knowledge, Skills And Abilities: Strong working knowledge of pharmaceutical analytical testing and demonstrated ability to interpret analytical, stability, and manufacturing data to drive technical decisions.
• Strong understanding of GMP requirements, ICH guidelines, and regulatory expectations for pharmaceutical development and manufacturing.
• Demonstrated experience managing CDMOs and working effectively in an outsourced development and manufacturing environment.
• Strong scientific judgment with the ability to constructively challenge assumptions and influence Quality, Regulatory CMC, external partners, and cross-functional stakeholders.
• Business-oriented and pragmatic, with the ability to balance technical requirements with risk, timeline, cost, and supply considerations.
• Experience in a small company environment strongly preferred.
• Must be available for some teleconferences outside of standard California business hours.
• Able to travel up to 30% of time required.

Pay

The salary range for this position is $200,000 to $215,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location.