Associate Director, Structural Characterization & CMC

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Flexible time off

Paid holidays

Tuition reimbursement

Student loan assistance

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Analytical – Structural Characterization to lead strategy and execution of small molecule structural characterization across development stages.

You will drive analytical methods, interpret data for CMC decisions, and collaborate with process chemistry, formulation, manufacturing, quality, and regulatory teams in a fast‑paced environment.

Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field, or MS with significant industry experience.
• 8–10+ years of small molecule analytical development experience in pharma/biotech.
• Demonstrated expertise in structural elucidation, impurity characterization, and solid‑state chemistry.
• Experience supporting CMC development and regulatory submissions (IND/NDA).
• Prior people leadership or matrix leadership experience preferred.

Responsibilities

• Scientific & Technical Leadership: provide SME for small molecule structural characterization and impurities.
• Define and execute analytical strategies to support process development, scale‑up, comparability, lifecycle management.
• Lead investigations of complex analytical/CMC issues related to structure, impurities, and stability.
• Interpret and integrate analytical data to guide critical CMC and development decisions.
• Partner with Process Chemistry, Formulation, Manufacturing, Quality, and Regulatory Affairs.

Skills

Scientific & Technical Leadership

Cross‑Functional Collaboration

People & Project Leadership

Strategic Thinking & Problem Solving

Impactful Communication

Education

PhD in Analytical Chemistry or related field

Tools

NMR

MS (LC-MS, HRMS)

IR/Raman/UV

HPLC/UPLC

GC

XRPD

DSC

TGA

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Analytical – Structural Characterization to lead strategy and execution of small molecule structural characterization across development stages.

You will drive analytical methods, interpret data for CMC decisions, and collaborate with process chemistry, formulation, manufacturing, quality, and regulatory teams in a fast‑paced environment.