Director, Drug Product & Process Development (Small Molecules)

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 186,489 - 278,875; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision coverage

401(k) match

Flexible time off

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Director of Drug Product Development to lead late-stage development activities for oral solid dosage form drug products. The role involves overseeing formulation, process development, and regulatory submissions while ensuring compliance with industry standards.

Ideal candidates will have over 10 years of experience, including substantial involvement in NDA submissions and FDA inspections. A competitive compensation package includes benefits such as medical coverage, tuition reimbursement, and more.

Qualifications

• 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.

Responsibilities

• Lead late-stage development of oral solid dosage forms and ensure consistency during scale-up.
• Author and support regulatory submissions, ensuring compliance with FDA standards.
• Oversee technology transfer of processes to commercial sites and troubleshoot issues.

Skills

Oral solid dosage form (OSD) drug product development

Regulatory submissions (NDA)

Cross-functional collaboration

Technical oversight of CDMOs

Leadership and mentorship

Problem-solving abilities

Education

PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry

Job description

Overview

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.

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 & Experience: 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 & Competencies: 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 include accountability for results, strategic thinking and problem solving, patient & customer centricity, impactful communication, respectful collaboration, and empowered development.

• Compensation & Benefits: Minimum $186,489.00 – Maximum $278,875.00, plus incentive opportunity. This range represents a typical pay range for the United States and may be adjusted based on experience, skills, and internal equity. Other elements may be used to determine actual pay. This information is provided to applicants in accordance with states and local laws.

• Application Deadline & Benefits: This position will be posted for a minimum of 5 business days. Company benefits include comprehensive medical, dental, vision, prescription drug coverage, life insurance, disability insurance, tuition reimbursement, student loan assistance, a 401(k) match, flexible time off, paid holidays, and paid leave programs. For more information, visit the company careers page.

Disclaimer & Equal Opportunity

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be considered 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 in accordance with applicable law.