Analytical Development Strategy Lead, Small Molecules

Otsuka Pharmaceutical Co., Ltd; United States; On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Tuition reimbursement

Paid leave

Life insurance

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an Associate Director, Analytical Development (Small Molecules) in the United States to lead strategy, execution and portfolio governance for analytical development from early development through NDA submission and commercialization.

The role owns analytical strategy and NDA positioning, interfaces with Regulatory Affairs and Health Authorities, and builds scalable analytical capability while driving risk-based decision making and external partner governance.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline; or M.S. with extensive, directly relevant 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.
• Demonstrated experience contributing to NDA analytical strategy and Health Authority engagement.
• Experience leading analytical functions in outsourced/CDMO-based development models.

Responsibilities

• Develop and govern portfolio level analytical strategy across small molecules.
• Own analytical narratives for NDAs and interact with FDA and global Health Authorities.
• Lead analytical risk management and lifecycle planning.
• Define governance models for CDMOs/CROs and oversee outsourcing strategy.
• Collaborate with Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.

Skills

Strategic analytical leadership

Regulatory engagement

Cross-functional leadership

Education

Ph.D. in Analytical Chemistry

M.S. in related field

Tools

HPLC/UPLC

GC

XRPD

DSC

TGA

Job description

Otsuka Pharmaceutical Co., Ltd. seeks an Associate Director, Analytical Development (Small Molecules) in the United States to lead strategy, execution and portfolio governance for analytical development from early development through NDA submission and commercialization.

The role owns analytical strategy and NDA positioning, interfaces with Regulatory Affairs and Health Authorities, and builds scalable analytical capability while driving risk-based decision making and external partner governance.