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

The Associate Director, Drug Product & Process   Development,   will provide technical and strategic leadership for   late ‑ stage   drug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), and   post ‑ approval   lifecycle management (LCM). This role will serve as a key CMC contributor to   cross ‑ functional   program teams, ensuring robust, scalable, and   regulatory ‑ compliant   drug product processes from Phase 2/3 through commercialization and beyond.

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 , including   scale ‑ 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, 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 .

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 .

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