Senior Director, Analytical Development and Quality Control (Small Molecules)

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Analytical Development and Quality Control for Small Molecules at our Wyoming, Kent County facility. Lead strategic oversight of all analytical capabilities supporting drug development, clinical manufacturing, commercial production, and pharmaceutical lifecycle management.

About the Role

As Senior Director, you'll direct a comprehensive analytical function spanning method development, validation, quality assurance, and regulatory affairs. You'll establish the analytical vision and strategy that ensures product quality, manufacturing reliability, and compliance with FDA and international standards. This senior leadership position is central to bringing small molecule therapeutics from development through commercialization and sustained market presence.

What You'll Do

• Develop and execute analytical strategies for drug substances and drug products throughout the development lifecycle
• Oversee analytical method development, qualification, and validation activities that support clinical and commercial manufacturing
• Build and manage high-performing teams focused on quality control and analytical testing
• Ensure all analytical operations meet FDA, ICH, and other regulatory requirements
• Collaborate with development, manufacturing, and regulatory teams to solve technical challenges and support filing strategies
• Drive continuous improvement initiatives to enhance analytical capabilities and operational efficiency
• Provide technical leadership on stability studies, analytical lifecycle management, and method transfer activities

What We're Looking For

• Advanced degree in Chemistry, Pharmaceutical Sciences, or related field
• 15+ years of analytical development and quality control experience in small molecule pharmaceuticals
• Proven success in a senior leadership role within pharmaceutical manufacturing or development
• Deep expertise in analytical techniques relevant to small molecule characterization and testing
• Strong knowledge of FDA regulations, ICH guidelines, and GMP requirements
• Demonstrated ability to lead cross-functional teams and drive technical strategy
• Excellent communication skills and ability to work collaboratively across organizational functions

About Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. develops and manufactures innovative pharmaceutical products that serve patients across multiple therapeutic areas. The company is committed to bringing quality medicines to market through rigorous scientific standards and operational excellence.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.