Director – Drug Product & Process Development - Small Molecules

The Director, Drug Product Development will lead late‑stage development and NDA‑enabling activities for oral solid dosage form (OSD) drug products. This role is responsible for execution of formulation, process development, scale‑up, validation, and regulatory deliverables to support NDA submission, regulatory review, and commercial launch. The Director will act as the Drug Product CMC lead for assigned late‑stage programs, working cross‑functionally and with external manufacturing partners to ensure robust, compliant, and inspection‑ready drug products.

Key Responsibilities

Late‑Stage OSD Development & Execution

• Lead late‑stage development of oral solid dosage forms (e.g., IR, MR, XR and complex formulations).
• Finalize commercial formulations and manufacturing processes including blending, granulation, compression, coating, and encapsulation.
• Ensure drug product design is robust, scalable, and aligned with registration and commercial manufacturing requirements.
• Support scale‑up activities and ensure consistency between clinical, registration, and commercial processes.
• Conduct and document risk assessments for CQAs and CPPs; implement mitigation strategies as needed.

NDA & Regulatory Submission Support

• Lead execution of drug product CMC activities for NDA submission for assigned programs.
• Author, review, and approve NDA Module 3 sections related to oral solid dosage form development, manufacturing, and controls.
• Support responses to FDA and health authority information requests during NDA review.
• Participate in regulatory meetings and contribute to pre‑approval inspection (PAI) readiness activities.
• Ensure drug product development activities comply with FDA, ICH, and internal quality standards.

Process Characterization, Validation & Tech Transfer

• Lead or support process characterization studies and PPQ activities for OSD products.
• Support continued process verification planning in collaboration with Quality and Manufacturing.
• Execute technology transfer of oral solid dosage form processes to commercial manufacturing sites or CDMOs.
• Troubleshoot late‑stage manufacturing and scale‑up issues related to OSD unit operations.

External Manufacturing & CDMO Management

• Provide day‑to‑day technical oversight of CDMOs manufacturing oral solid dosage forms.
• Review development reports, batch records, and validation documentation from external partners.
• Work with Quality and Supply Chain to support launch readiness and reliable supply.

Cross‑Functional Collaboration

• Serve as the drug product CMC representative on late‑stage program teams.
• Collaborate closely with Drug Substance, Analytical Development, Regulatory Affairs, Quality, Manufacturing, and Program Management.
• Communicate development risks, timelines, and mitigation plans to functional and program leadership.

People & Operational Leadership

• Lead and mentor a small team of scientists and engineers supporting oral solid dosage form development.
• Provide technical guidance, performance feedback, and development coaching.
• Manage project‑level budgets, outsourcing activities, and timelines for assigned programs.

Lifecycle & Post‑Approval Support

• Support post‑approval change management activities including comparability assessments and CBE submissions.
• Contribute to continuous improvement initiatives focused on process robustness, manufacturability, and cost‑of‑goods.
• Provide ongoing technical support for commercial oral solid dosage form products as needed.

Qualifications

Education

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline.

Experience

• 10–12+ years of experience in oral solid dosage form drug product and process development.
• Demonstrated experience supporting late‑stage development and at least one NDA submission.
• Experience supporting FDA inspections or PAI readiness for OSD manufacturing sites.
• Hands‑on experience working with CDMOs and commercial manufacturing environments.

Technical Expertise

• Strong expertise in OSD formulation and unit operations.
• Working knowledge of QbD principles, control strategies, process validation, and lifecycle management.
• Experience addressing common OSD challenges such as content uniformity, dissolution performance, and scale‑up risks.

Leadership & Communication

• Proven ability to lead cross‑functional project teams and execute against aggressive timelines.
• Clear, concise communicator with strong technical writing skills.
• Practical, execution‑focused mindset with strong problem‑solving abilities.

Preferred Qualifications

• Experience with modified‑release or bioavailability‑enhanced OSD formulations.
• Prior support of commercial product launch activities.
• Experience working in partially or fully outsourced development models.

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 $186,489.00 - Maximum $278,875.00, 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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