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

Otsuka Pharmaceutical Co., Ltd.

1d • $169,222 - $253,000 • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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.
• 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).
• 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.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree