Associate Director, Analytical: Structural Characterization

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Tuition reimbursement

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an Associate Director for Analytical – Structural Characterization to lead strategy and execution of small molecule structural analysis across development stages.

This role ensures understanding of molecular structure, impurities, solid-state form, and degradation behavior to support process development, regulatory submissions, and commercialization. You will oversee method development/validation, CMC support for IND/NDA, and collaborate with Process

Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences or MS with significant industry experience.
• 8–10+ years of small molecule analytical development experience in pharma/biotech.
• Expertise in structural elucidation, impurity characterization, and solid-state chemistry.
• Experience supporting CMC development and regulatory submissions (IND/NDA).

Responsibilities

• Provide SME leadership for small molecule structural characterization including identity, impurity profiling, and degradation pathways.
• Oversee method development/qualification/validation for spectroscopic and chromatographic techniques and solid-state methods.
• Support CMC strategies for IND, NDA, and post-approval submissions; author/regulatory responses.
• Collaborate with Process Chemistry, Formulation, Manufacturing, Quality, and Regulatory Affairs.
• Lead analytical projects, ensure timely, high-quality deliverables and scalable processes.

Skills

Small molecule analytics

Analytical strategy leadership

GxP-regulated experience

Cross-functional collaboration

Data interpretation

Problem solving

Regulatory submissions support

Education

PhD or MS in Analytical/Organic/Pharmaceutical Chemistry

Job description

Otsuka Pharmaceutical Co., Ltd. seeks an Associate Director for Analytical – Structural Characterization to lead strategy and execution of small molecule structural analysis across development stages.

This role ensures understanding of molecular structure, impurities, solid-state form, and degradation behavior to support process development, regulatory submissions, and commercialization. You will oversee method development/validation, CMC support for IND/NDA, and collaborate with Process