Director, Drug Product & Process Development (Small Molecules)

Otsuka America Pharmaceutical Inc.; Tallahassee (FL); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

Tuition reimbursement

401(k) with match

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director of Drug Product Development to lead late-stage OSD development and NDA-enabling activities.

This role serves as the Drug Product CMC lead, coordinating formulation, process development, scale-up, validation, and regulatory deliverables for NDA submission and launch. The position requires oversight of cross-functional teams, external CDMOs, and collaboration with Regulatory, Quality, and Manufacturing to ensure robust, scalable, and

Qualifications

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline.
• 10–12+ years in oral solid dosage drug product and process development.
• Experience supporting late-stage development and at least one NDA submission.
• Experience with CDMOs and commercial manufacturing environments.

Responsibilities

• Lead late-stage development of oral solid dosage forms (IR, MR, XR, complex formulations).
• Finalize commercial formulations and processes including blending, granulation, compression, coating, encapsulation.
• Lead drug product CMC activities for NDA submissions and module 3 preparation.

Skills

OSD formulation

Process development

Regulatory submissions

Education

PhD/MS in Pharmaceutical Sciences / related

Job description

Remote

Full time

R12442

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.

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.

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 Accommodation Request ([e-mail]) .

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.