Associate Director, Drug Product & Process Development; Molecules

The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for late‑stage drug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), and post‑approval lifecycle management (LCM). This role will serve as a key CMC contributor to cross‑functional program teams, ensuring robust, scalable, and regulatory‑compliant drug product processes from Phase 2/3 through commercialization and beyond.

• Lead late‑stage drug product development activities (Phase 2/3 through commercial launch), including formulation optimization, process validation readiness, and robustness studies.
• Provide technical oversight for drug product manufacturing processes, including scale‑up, tech transfer, PPQ, and commercial manufacturing support.
• Ensure development strategies align with Quality by Design (QbD) principles, with clearly defined CMAs, CPPs, and control strategies.
• Author and review technical development plans, process descriptions, development reports, and validation summaries.

• Serve as a CMC drug product lead for NDA (and/or MAA) filings, including preparation and review of Modules 2.3 and 3 sections related to drug product and manufacturing processes.
• Support Health Authority interactions (FDA, EMA, etc.), including information requests, deficiency responses, and commitment fulfillment.
• Ensure drug product development content is compliant with current regulatory expectations and global guidelines (e.g., ICH Q8–Q12).

• Lead and support post‑approval LCM activities, including 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.

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+ years of relevant industry experience OR
• MS with 8+ years / BS with 10+ years of progressive experience in drug product/process development

• Demonstrated experience in late‑stage drug product development (Phase 3 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 (tailor as needed)
• Familiarity with commercial manufacturing and supply support
• Prior people leadership or matrix leadership experience

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…