Strategic Lead, Small Molecules Analytical Development

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid time off & holidays

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Companies (U.S.) seeks an Associate Director of Analytical Development (Small Molecules) to lead strategy, execution, and portfolio analytics from early development through NDA submission and commercialization. You will own analytical control strategies, manage regulatory interactions, and build scalable capabilities across programs.

The role requires 12–15+ years in pharma/biotech analytical development, with deep expertise in stability, impurities, and regulatory

Qualifications

• Ph.D. or M.S. with extensive industry experience in small‑molecule analytics.
• 12–15+ years in pharma/biotech analytical development; NDA experience preferred.
• Proven leadership of analytical programs from early development through NDA/approval.

Responsibilities

• Lead analytical strategy and governance for small molecule programs from early development to commercialization.
• Own NDA analytical narrative and regulatory interactions with FDA and Health Authorities.
• Manage analytical risk, method lifecycle, validation timing, and comparability strategies.
• Define governance models for CDMOs/CROs and vendor oversight in collaboration with Quality and Procurement.
• Mentor and develop Senior Managers, build scalable analytical capabilities.

Skills

Analytical leadership

Regulatory liaison

Risk management

Cross-functional leadership

Strategic thinking

Education

Ph.D. in Analytical Chemistry or Pharmaceutical Sciences

M.S. in related field

Tools

HPLC/UPLC

GC

XRPD

DSC

TGA

ICH guidelines

Job description

Otsuka Pharmaceutical Companies (U.S.) seeks an Associate Director of Analytical Development (Small Molecules) to lead strategy, execution, and portfolio analytics from early development through NDA submission and commercialization. You will own analytical control strategies, manage regulatory interactions, and build scalable capabilities across programs.

The role requires 12–15+ years in pharma/biotech analytical development, with deep expertise in stability, impurities, and regulatory