Associate Director, Drug Product & Process Development (Small Molecules)

Join Otsuka America Pharmaceutical Inc. as an Associate Director of Drug Product & Process Development (Small Molecules) in Boston, Suffolk County. This full-time leadership role offers the opportunity to drive late-stage pharmaceutical development programs from characterization through commercialization.

About the Role

As Associate Director of Drug Product & Process Development, you will lead technical and strategic initiatives across small-molecule development programs. You'll oversee process characterization, scale-up strategies, and manufacturing control systems while serving as a core Chemistry, Manufacturing, and Controls (CMC) contributor on multidisciplinary teams. Your work will span regulatory submissions including IND amendments and NDA/MAA filings, as well as post-approval lifecycle management to ensure continued product quality and compliance throughout the commercial lifecycle.

What You'll Do

• Direct late-stage drug product development activities, including formulation optimization, manufacturing process design, and analytical method development
• Lead process characterization studies and establish control strategies aligned with ICH guidelines and FDA expectations
• Prepare and support CMC sections of regulatory submissions (IND amendments, NDA/MAA)
• Manage post-approval lifecycle activities, including process improvements, scale-up oversight, and regulatory interactions
• Collaborate with cross-functional teams—including manufacturing, quality, regulatory, and clinical—to advance development timelines and meet quality objectives
• Mentor junior technical staff and contribute to knowledge-sharing within the development organization

What We're Looking For

• Advanced degree (Ph.D., M.S., or equivalent) in pharmaceutical sciences, chemistry, chemical engineering, or a related field
• 5+ years of hands-on experience in pharmaceutical drug product development, process development, or manufacturing for small-molecule drugs
• Demonstrated expertise in formulation science, manufacturing scale-up, and process characterization
• Strong understanding of CMC requirements, FDA regulations, and pharmaceutical quality guidance documents
• Proven track record leading technical projects and cross-functional teams in fast-paced environments
• Excellent communication skills and the ability to translate complex technical concepts for diverse audiences

About Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is a leading research-driven pharmaceutical company committed to bringing innovative medicines to patients worldwide. We invest in small-molecule and biologics development across therapeutic areas, supported by a culture of scientific rigor and collaborative teamwork.

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.