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

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

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) with match

Paid time off and holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director to lead late-stage drug product development from Phase 2/3 through commercialization.

You will shape process characterization, control strategies, and lifecycle management while aligning with global regulatory expectations and CMC leadership across cross-functional teams. Responsibilities include guiding technology transfer, scale-up, NDA/MAA filings, and collaboration with CDMOs, Quality, Regulatory, and Manufacturing to ensure

Qualifications

• PhD or MS/BS with industry experience in late-stage drug product development.
• Experience with NDA/CMC submissions and regulatory agency interactions.
• Strong knowledge of QbD, CMAs, CPPs, and control strategies.
• Proven ability to lead cross-functional teams and mentor staff.

Responsibilities

• Lead late-stage drug product development activities (Phase 2/3 through launch).
• Provide technical oversight for drug product manufacturing processes (scale-up, tech transfer, PPQ, and commercial support).
• Ensure development strategies align with Quality by Design (QbD) principles and control strategies.
• Author and review development plans, process descriptions, development reports, and validation summaries.
• Serve as CMC lead for NDA/MAA filings and regulatory interactions.
• Lead post-approval lifecycle management (LCM) activities and changes.

Skills

Late-stage drug product development

NDA CMC submissions

Drug product manufacturing & scale-up

CMC regulatory knowledge

LCM post-approval changes

Cross-functional collaboration

Technical writing

Education

PhD in Pharmaceutics/related field

MS with 8+ years / BS with 10+ years of experience

Job description

Remote

Full time

R12455

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, 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
• Provenexpertisein drug product manufacturing processes, scale‑up, tech transfer, and validation
• Strong understanding of CMC regulatory requirements and global regulatory frameworks
• Hands‑onexperience with LCM strategies and post ‑ approval changes
• 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.

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.

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.