Analytical Development Leader, Small Molecules & NDA

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Paid holidays and leave programs

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Analytical Development (Small Molecules) to lead analytical strategy and governance for multiple programs from early development through NDA submission and commercialization.

You will own NDA analytical positioning, engage with FDA/Health Authorities, and build scalable analytical capability across the organization, mentoring Senior Managers and cross-functional teams to align with late-stage and commercial needs.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline; or MS with extensive industry experience.
• 12–15+ years of pharmaceutical or biotech industry experience in small‑molecule analytical development.
• Demonstrated leadership of programs from early development through NDA filing and approval.
• Experience leading analytical functions in outsourced/CDMO-based development models.

Responsibilities

• Develop and govern portfolio-level analytical strategies for small-molecule programs from early development through NDA and commercialization.
• Own analytical narratives and positioning for NDAs, coordinating across Drug Substance, Drug Product, impurities, stability, and control strategies.
• Lead risk-based assessments and lifecycle planning for method validation, specification setting, and comparability.
• Define and implement analytical governance models for CDMOs/CROs and ensure inspection readiness.
• Serve as strategic partner to Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain; influence development timelines and strategies.
• Mentor Senior Managers and Managers; scale analytical capabilities for late-stage and commercial needs.

Skills

Analytical Strategy

Regulatory Leadership

NDA Strategy

Leadership

Education

PhD in Analytical Chemistry or related

MS in related field

Job description

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director, Analytical Development (Small Molecules) to lead analytical strategy and governance for multiple programs from early development through NDA submission and commercialization.

You will own NDA analytical positioning, engage with FDA/Health Authorities, and build scalable analytical capability across the organization, mentoring Senior Managers and cross-functional teams to align with late-stage and commercial needs.