Materials Science Lead — Solid-State & IND/NDA Strategy

Otsuka America Pharmaceutical Inc.; Phoenix (AZ); On-site; USD 169,222 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid holidays

Paid leave

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Materials Science to lead scientific leadership for small molecule drug programs, focusing on solid‑state form selection, material control strategies, and technology transfer to clinical and commercial manufacturing.

The role requires deep expertise in small molecule materials science, cross‑functional leadership, and support for regulatory submissions in GMP environments.

Qualifications

• 8–12+ years of experience in pharmaceutical or biotech drug development with a focus on small molecule programs.
• Proven track record contributing to IND and NDA submissions.

Responsibilities

• Serve as subject matter expert in solid-state chemistry, physicochemical characterization, and structure–property–process relationships.
• Design, interpret, and oversee material characterization using XRPD, DSC, TGA, DVS, spectroscopy, microscopy, and particle size analysis.
• Define CMAs and their linkage to formulation performance, process robustness, and product quality.
• Establish material control strategies to ensure manufacturability and long-term stability.
• Lead initial material science approach to support IND-enabling activities, including solid-state form screening and selection.
• Lead material risk assessments and mitigation strategies; support prototype formulation development with material rationale.

Skills

Solid-state chemistry

Polymorphism

Salt selection

Particle engineering

Material characterization

QbD

Risk assessment

Regulatory writing

Cross-functional leadership

Strategic thinking

Decision making

Education

PhD in Materials Science or related field

MS with substantial industry experience

Tools

XRPD

DSC

TGA

DVS

Spectroscopy

Microscopy

Particle size analysis

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Materials Science to lead scientific leadership for small molecule drug programs, focusing on solid‑state form selection, material control strategies, and technology transfer to clinical and commercial manufacturing.

The role requires deep expertise in small molecule materials science, cross‑functional leadership, and support for regulatory submissions in GMP environments.