Strategic Leader, Small Molecule Analytical Development

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid holidays and leave

Job summary

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

The role interfaces with Regulatory Affairs and Health Authorities, defining control strategies and ensuring regulatory success while building scalable analytical capabilities across the organization.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• M.S. with extensive, directly relevant industry experience.

Responsibilities

• Lead strategy, execution, and governance for analytical development of small molecules.
• Own NDA analytical positioning and regulatory interactions with Health Authorities.
• Manage analytical risk, method lifecycle, and specifications.
• Partner with CDMOs/CROs for outsourcing strategies and inspection readiness.
• Collaborate with Regulatory Affairs, Quality, and MSAT for CMC leadership.

Skills

Strategic leadership

Regulatory writing

Cross-functional collaboration

Communication

Problem solving

Education

Ph.D./MS in analytical-related field

Advanced industry experience

Job description

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

The role interfaces with Regulatory Affairs and Health Authorities, defining control strategies and ensuring regulatory success while building scalable analytical capabilities across the organization.