Lead Materials Scientist – Solid-State & Drug Substance

Jit Global Freight Solution P Ltd; New Brunswick (NJ); On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

Generous 401(k) match

Tuition reimbursement

Paid holidays & leave programs

Life/disability insurance

Job summary

Otsuka seeks an Associate Director of Materials Science to lead strategic material science for small molecule programs through IND and NDA. You will define CMAs, supervise characterization, and guide technology transfer to clinical and commercial manufacturing.

The role requires deep expertise in solid‑state chemistry, risk assessment, and regulatory writing, with strong cross‑functional collaboration across MSAT, Process Development, and Manufacturing.

Qualifications

• PhD in Materials Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• 8–12+ years of pharma/biotech drug development experience, with strong focus on small molecule programs.
• Demonstrated experience supporting IND/NDA submissions and technology transfer to manufacturing.

Responsibilities

• Lead material science strategy for small molecule programs, including solid‑state form selection and particle engineering.
• Serve as SME in solid‑state chemistry, characterization, and structure‑property‑process relationships.
• Define CMAs and link material attributes to formulation performance and process robustness.
• Author and align NDA/CMC sections related to materials and lifecycle management.
• Support health authority interactions and tech transfer from development to clinical/manufacturing sites.

Skills

Solid‑state chemistry

Polymorphism

Salt selection

Particle engineering

Material characterization

Formulation development

GMP manufacturing

QbD & risk assessments

Regulatory writing

Cross-functional leadership

Education

PhD in Materials Science/Pharmaceutical Sciences/Chemistry/Engineering

MS with substantial relevant industry experience

Job description

Otsuka seeks an Associate Director of Materials Science to lead strategic material science for small molecule programs through IND and NDA. You will define CMAs, supervise characterization, and guide technology transfer to clinical and commercial manufacturing.

The role requires deep expertise in solid‑state chemistry, risk assessment, and regulatory writing, with strong cross‑functional collaboration across MSAT, Process Development, and Manufacturing.