Associate Director, Drug Product & Process Development (Small 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.

Key Responsibilities

Drug Product & Process Development 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. Regulatory Filings & Health Authority Interactions 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). Lifecycle Management (LCM) 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. Cross‑Functional Leadership 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.

Qualifications

Education 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 Required Experience & Skills 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

Preferred Qualifications

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 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. Application Deadline: This will be posted for a minimum of 5 business days. 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. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. 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