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

Otsuka America Pharmaceutical Inc.; Dover (DE); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

A generous 401(k) match

Tuition reimbursement

Paid holidays

Flexible time off

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a senior specialist to lead late-stage drug product development from Phase 2/3 through commercial launch, overseeing formulation optimization, process validation readiness, and robustness studies.

You will drive CMC-related NDA submissions, manage tech transfer, and ensure alignment with QbD and regulatory expectations across global frameworks.

Qualifications

• Late-stage drug product development experience (Phase 3 to commercial).
• Direct involvement in NDA 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.

Responsibilities

• Lead late-stage drug product development activities from Phase 2/3 through launch, including formulation optimization and robustness studies.
• Provide technical oversight for manufacturing processes, scale-up, tech transfer, PPQ, and commercial support.
• Ensure development strategies align with QbD principles, with clearly defined CMAs, CPPs, and control strategies.
• Author and review development plans, process descriptions, development reports, and validation summaries.
• Serve as a CMC drug product lead for NDA filings, including preparation/review of Modules 2.3 and 3 sections.
• Lead post-approval lifecycle management activities including formulation changes and site transfers.
• Mentor and guide junior scientists and engineers; contribute to building organizational CMC capabilities.

Skills

Late-stage drug product development

CMC regulatory submissions

Drug product manufacturing processes

Scale-up & tech transfer

Cross-functional leadership

Regulatory knowledge (FDA/EMA)

Education

PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline

MS with 8+ years / BS with 10+ years of experience in drug product/process development

Job description

Remote

Full time

R12455

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, includingscale‑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
• paid leave programs
• other company provided benefits

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 [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.