Job Description

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.

Key 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.

Qualifications

Education

• PhD in Materials Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
  or
• MS with substantial relevant industry experience

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).

Technical Expertise

• 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

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka

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