Lead, Drug Product & Process Development (Small Molecules)

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive health plan

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Drug Product & Process Development (Small Molecules) to lead late-stage development activities remotely from the United States. You will drive formulation optimization, process characterization, and scalable manufacturing to support Phase 2/3 through commercialization, ensuring QbD-aligned control strategies.

You will oversee regulatory filings (NDA/MAA), health authority interactions, and post-approval lifecycle management while

Qualifications

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related with 5+ years industry experience OR MS with 8+ years / BS with 10+ years.
• Experience in late-stage drug product development (Phase 3 to commercial).
• Direct NDA/CMC submissions involvement and regulatory agency interactions.
• Hands-on with DP manufacturing processes, scale-up, and validation.
• Strong understanding of CMC regulatory requirements and global frameworks.
• Experience with LCM strategies and post-approval changes.
• Excellent writing, communication, and cross-functional collaboration.

Responsibilities

• Lead late-stage drug product development activities (Phase 2/3 through commercialization).
• Provide technical oversight for drug product manufacturing processes, scale-up, tech transfer, PPQ, and commercial support.
• Ensure development strategies align with QbD principles with CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, reports, and validation summaries.
• Support regulatory filings and Health Authority interactions (FDA, EMA).
• Lead post-approval lifecycle management activities and drive continuous improvement.
• Mentor and guide junior scientists and engineers; collaborate across functions.

Skills

Late-stage development

NDA/CMC submissions

Tech transfer

Scale-up

CMC knowledge

Regulatory interactions

Education

PhD in Pharmaceutics/related

MS in related field

BS in related field

Job description

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Drug Product & Process Development (Small Molecules) to lead late-stage development activities remotely from the United States. You will drive formulation optimization, process characterization, and scalable manufacturing to support Phase 2/3 through commercialization, ensuring QbD-aligned control strategies.

You will oversee regulatory filings (NDA/MAA), health authority interactions, and post-approval lifecycle management while