Associate Director, Drug Product & Process Development; Molecules

Job Summary

The Associate Director, Drug Product & Process Development provides technical and strategic leadership for late‑stage drug product development programs, including process characterization, control strategy development, regulatory filings, and post‑approval lifecycle management.

• Lead late‑stage drug product development activities (Phase2/3 through commercial launch): formulation optimization, process validation readiness, and robustness studies.
• Provide technical oversight for manufacturing processes: scale‑up, tech transfer, PPQ, and commercial manufacturing support.
• Ensure development strategies align with Quality by Design (QbD) principles: clearly defined CMAs, CPPs, and control strategies.
• Author and review technical development plans, process descriptions, development reports, and validation summaries.

• Serve as CMC drug product lead for NDA and/or MAA filings: preparation and review of Modules
  2.3 and3 sections.
• Support health authority interactions: information requests, deficiency responses, and commitment fulfillment.
• Ensure compliance with regulatory expectations and global guidelines (e.g., ICHQ8–Q12).

• Lead and support post‑approval LCM activities: formulation changes, site transfers, process improvements, specification updates, and alternate sourcing.
• Assess change impact and support regulatory submissions: PAS, CBE‑30, annual reports, variations.
• Drive continuous improvement initiatives to enhance process robustness, manufacturability, and supply reliability.

• Act as a technical representative on cross‑functional program teams (Regulatory, Quality, Manufacturing, Supply Chain, Clinical, and Commercial).
• Provide technical direction to CMOs/CDMOs, ensuring alignment with development strategy, timelines, and quality standards.
• Mentor and guide junior scientists and engineers; contribute to building organizational CMC capabilities.

• Ph.D. in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+years of relevant industry experience OR M.S. with 8+years OR B.S. with 10+years of progressive experience in drug product/process development.
• Demonstrated experience in late‑stage drug product development (Phase3 to commercial).
• Direct involvement in NDA (or equivalent) CMC submissions, including authorship and regulatory agency interactions.
• Proven expertise in drug product manufacturing processes, scale‑up, tech transfer, and validation.
• Strong understanding of CMC regulatory requirements and global regulatory frameworks.
• Hands‑on experience with LCM strategies and post‑approval changes.
• Excellent technical writing, communication, and cross‑functional collaboration skills.

• Experience working with external manufacturing partners (CDMOs).
• Experience with aseptic, solid oral, or other relevant dosage forms.
• Familiarity with commercial manufacturing and supply support.
• Prior people leadership or matrix leadership experience.

• Accountability for results – focus on key strategic objectives, high standards of performance, and leading change.
• Strategic thinking & problem solving – make decisions considering long‑term impact.
• Patient & customer centricity – maintain focus on stakeholder needs.
• Impactful communication – clear, respectful communication at all levels.
• Respectful collaboration – value diverse perspectives and partnerships.
• Empowered development – active role in professional development.

Minimum$–Maximum$, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the role to perform in the United States.

• Comprehensive medical, dental, vision, and prescription drug coverage
• Company‑provided basic life, accidental death & dismemberment, short‑term and long‑term disability insurance
• Tuition reimbursement and student loan assistance
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs
• Other company‑provided benefits

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation.