Associate Director, Late-Stage Drug Product Development

Otsuka America Pharmaceutical Inc.; Olympia (WA); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Company provided basic life

Accidental death & dismemberment

Short-term and long-term disability

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Other company provided benefits

Job summary

Otsuka America Pharmaceutical Inc. seeks a senior leader to guide late-stage drug product development from Phase 3 through commercial launch, driving robust formulation, process validation readiness, and QbD-aligned strategies across cross-functional teams.

The role oversees manufacturing processes, tech transfer, and NDA/CMC submissions, with responsibility for regulatory interactions and post-approval changes.

Qualifications

• Demonstrated experience in late-stage drug product development (Phase 3 to commercial).
• Direct involvement in NDA/CMC submissions and regulatory agency interactions.
• Strong understanding of drug product manufacturing processes, scale-up, tech transfer and validation.

Responsibilities

• Lead late-stage drug product development activities through launch.
• Provide technical oversight for drug product manufacturing processes, scale-up and tech transfer.
• Align development strategies with Quality by Design (QbD) principles and control strategies.
• Author and review development plans, reports, and validation summaries.
• Serve as CMC drug product lead for NDA filings and regulatory submissions.
• Support health authority interactions (FDA/EMA) and regulatory responses.
• Lead post-approval LCM activities and ongoing process improvements.
• Mentor junior scientists and collaborate with cross-functional teams.

Skills

Late-stage development

NDA CMC submissions

Drug product manufacturing

CMC regulatory requirements

LCM post-approval changes

Technical writing & collaboration

Education

PhD in Pharmaceutics/related

MS in related field (with experience)

Job description

Otsuka America Pharmaceutical Inc. seeks a senior leader to guide late-stage drug product development from Phase 3 through commercial launch, driving robust formulation, process validation readiness, and QbD-aligned strategies across cross-functional teams.

The role oversees manufacturing processes, tech transfer, and NDA/CMC submissions, with responsibility for regulatory interactions and post-approval changes.