The Associate Director, Drug Product & ProcessDevelopment,will provide technical and strategic leadership forlate‑stagedrug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), andpost‑approvallifecycle management (LCM). This role will serve as a key CMC contributor tocross‑functionalprogram teams, ensuring robust, scalable, andregulatory‑compliantdrug product processes from Phase 2/3 through commercialization and beyond.
Key Responsibilities
Drug Product & Process Development
Lead late‑stagedrug 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‑approvalLCM 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‑FunctionalLeadership
Act as a technical representative on cross‑functionalprogram 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‑stagedrug product development (Phase 3 to commercial)
Direct involvement in NDA (or equivalent) CMC submissions, including authorship and regulatory agency interactions
Provenexpertisein drug product manufacturing processes,scale‑up, tech transfer, and validation
Strong understanding of CMC regulatory requirementsand global regulatory frameworks
Hands‑onexperience with LCM strategies andpost‑approvalchanges
Excellent technical writing, communication, andcross‑functionalcollaboration 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
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 employerAll 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
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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
There are two Otsuka pharmaceutical industry companies in the U.S.:
Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.
