Associate Director, Material Science

Otsuka Pharmaceutical Co., Ltd.

1d • $169,222 - $253,000 • Onsite

About The Position

The Associate Director, Materials Science will lead scientific strategic leadership for small molecule drug development programs, with accountability for material understanding, solid-state control, and material-related risk management from IND through NDA and commercialization. This role plays a critical part in ensuring robust solid-state form selection, particle and material control strategies, and successful technology transfer to clinical and commercial manufacturing. The position requires deep expertise in small molecule materials science, strong cross-functional leadership, and experience supporting regulatory submissions in a GMP environment.

Requirements

• PhD in Materials Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field or MS with substantial relevant industry experience
• Typically 8–12+ years of experience in pharmaceutical or biotech drug development, with a strong focus on small molecule programs.
• Demonstrated experience supporting oral solid dosage forms (preferred).
• Proven track record contributing to IND and NDA submissions.
• Experience with technology transfer and commercial manufacturing (internal or CMOs).
• Solid-state chemistry, polymorphism, salt selection, and particle engineering
• Material characterization techniques and data interpretation
• Understanding of formulation development, scale-up, and GMP manufacturing
• Familiarity with QbD, risk assessments, and lifecycle management
• Strong written and verbal communication skills, including regulatory technical writing
• Ability to lead without authority and influence cross-functional teams
• Strategic thinker with strong problem-solving and decision-making skills

Responsibilities

• Contribute and execute material science strategy for small molecule drug substance and drug product programs, including solid-state form selection (salt, polymorph, amorphous), particle engineering, and excipient compatibility.
• Serve as subject matter expert in solid-state chemistry, physicochemical characterization, and structure–property–process relationships.
• Design, interpret, and oversee material characterization using techniques such as XRPD, DSC, TGA, DVS, spectroscopy, microscopy, and particle size analysis.
• Define critical material attributes (CMAs) and their linkage to formulation performance, process robustness, and product quality.
• Establish material control strategies to ensure consistent manufacturability and long-term product stability.
• Define the initial material science approach to support IND-enabling activities, including solid-state form screening and selection.
• Lead early material risk assessments (e.g., polymorphism, hygroscopicity, particle size sensitivity) and mitigation strategies.
• Support prototype formulation development (e.g., IR tablets, capsules) by providing material selection rationale and handling guidance.
• Support transfer of material knowledge from discovery to development and clinical manufacturing teams.
• Contribute to IND CMC sections related to material characterization, form selection, and control approaches.
• Lead comprehensive material characterization and comparability assessments to support scale-up, validation, and commercial readiness.
• Define and justify commercial material specifications and acceptance criteria.
• Author, review, and approve NDA/MAA CMC sections related to materials, solid-state control, and lifecycle management.
• Support health authority interactions and responses related to material science topics.
• Lead materials science activities for technology transfer from development to clinical and commercial manufacturing sites (internal and CMOs).
• Partner with MSAT, Process Development, Manufacturing, Quality, and External Manufacturing to ensure successful scale-up and site transfer.
• Support engineering, PPQ, and validation batches, providing scientific oversight for material-related performance.
• Identify, assess, and mitigate material-related risks during scale-up and validation.
• Lead or support investigations into material-driven deviations or performance issues during tech transfer and commercial manufacturing.
• Act as a key materials science representative on cross-functional CMC and project teams.
• Influence program strategy through data-driven recommendations and risk-based decision-making.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
• tuition reimbursement
• student loan assistance
• a generous 401(k) match
• flexible time off
• paid holidays
• paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior