Associate Director, Drug Product & Process Development (Small Molecules)

The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for early/late‑stage drug product development programs, including formulation design, process characterization, control strategy development, regulatory filings, and post‑approval lifecycle management (LCM), as needed. This role will serve as a key CMC contributor to cross‑functional program teams, ensuring robust, scalable, and regulatory‑compliant formulations and drug product processes from Phase 1/2 through Phase 3 and beyond. Key Responsibilities Drug Product & Process Development Lead early/late‑stage drug product development activities (Phase 1/2 through Phase 3) for oral, injectable and/or complex dosage forms, including formulation design & optimisation, process validation readiness, and robustness studies. Provide technical oversight for drug product manufacturing processes, including scale‑up, technical transfer, and 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 CMC/Drug Product Lead for early/late-phase regulatory filings, including preparation and review of 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). External Manufacturing & CDMO Management Provide technical oversight at CDMOs for formulation design and manufacturing of phase‑appropriate and patient‑centric dosage forms. Review development reports, batch records, and validation documentation from external partners. Work with Quality and Supply Chain to support reliable clinical supplies through development. Cross‑Functional Leadership Act as a technical representative and CMC/Drug Product Lead on cross‑functional program/CMC 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 early/late‑stage drug product development for small molecules. Direct involvement in regulatory CMC submissions, including authorship and regulatory agency interactions. Proven expertise in drug product manufacturing processes, scale‑up, technical 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 Demonstrated ability to drive integrated CMC/product development activities and connect the dots between cross‑functional CMC disciplines. Experience working with external manufacturing partners (CDMOs). Experience with sterile injectables, solid oral, and/or complex dosage forms. Familiarity with clinical 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; Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. 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. 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, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting View email address on click.appcast.io. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute. #J-18808-Ljbffr