Associate Director, Structural Characterization

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); Híbrido; USD 169.000 - 253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Descripción de la vacante

Otsuka Pharmaceutical Co., Ltd seeks an Associate Director, Analytical – Structural Characterization to lead the strategy and execution of small molecule structural characterization across all development phases. You will ensure deep understanding of molecular structure, impurities, solid‑state form, and degradation behavior to support process development, regulatory submissions, and commercialization.

The role requires strong technical expertise, cross‑functional leadership, and the ability to

Formación

• PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related discipline.
• 8–10+ years of small molecule analytical development experience.
• Expertise in structural elucidation, impurity characterization, and solid-state chemistry.
• Experience supporting CMC development and regulatory submissions (IND/NDA).
• Prior leadership or matrix leadership experience preferred.

Responsabilidades

• Provide subject matter expertise for small molecule structural characterization including identity, impurity profiling, degradation pathways, and solid-state properties.
• Define and execute analytical strategies to support process development, scale-up, comparability, and lifecycle management.
• Lead investigations and resolutions of complex analytical and CMC issues related to structure, impurities, and stability.
• Interpret and integrate analytical data to guide critical CMC and development decisions.
• Collaborate with Process Chemistry, Formulation, Manufacturing, Quality, and Regulatory teams.
• Manage external CROs/CDMOs and analytical vendors.

Conocimientos

Subject matter expertise

Cross-functional leadership

Data interpretation

Problem solving

Strategic thinking

Communication

GxP-regulated environments

Fast-paced environment

Educación

PhD in Analytical Chemistry

MS with significant industry experience

Herramientas

NMR

MS/LC-MS

HPLC/UPLC

XRPD/DSC/TGA

Descripción del empleo

Otsuka Pharmaceutical Co., Ltd seeks an Associate Director, Analytical – Structural Characterization to lead the strategy and execution of small molecule structural characterization across all development phases. You will ensure deep understanding of molecular structure, impurities, solid‑state form, and degradation behavior to support process development, regulatory submissions, and commercialization.

The role requires strong technical expertise, cross‑functional leadership, and the ability to