Associate Director, Drug Product & Process Development – Small Molecules

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🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Provide technical and strategic leadership for late-stage drug product development programs • Lead Phase 2/3 through commercial-launch activities, including formulation optimization, process validation readiness, and robustness studies • Provide technical oversight for manufacturing processes, scale-up, tech transfer, PPQ, and commercial manufacturing support • Ensure development strategies align with Quality by Design principles and defined CMAs, CPPs, and control strategies • Author and review technical development plans, process descriptions, development reports, and validation summaries • Serve as CMC drug product lead for NDA and/or MAA filings, including Modules 2.3 and 3 • Support FDA, EMA, and other Health Authority interactions, including information requests, deficiency responses, and commitment fulfillment • Lead and support post-approval lifecycle management activities, including formulation changes, site transfers, process improvements, specification updates, and alternate sourcing • Assess change impact and support regulatory submissions such as PAS, CBE-30, annual reports, and variations • Drive continuous improvement to enhance process robustness, manufacturability, and supply reliability • Represent drug product technical development on cross-functional program teams • Provide technical direction to CMOs/CDMOs • Mentor junior scientists and engineers and contribute to organizational CMC capabilities

🎯 Requirements

• 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 • Demonstrated experience in late-stage drug product development from Phase 3 to commercial • Direct involvement in NDA or equivalent CMC submissions, including authorship and regulatory agency interactions • 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 lifecycle management strategies and post-approval changes • Excellent technical writing, communication, and cross-functional collaboration skills • Experience with external manufacturing partners (CDMOs) preferred • Experience with aseptic, solid oral, or other relevant dosage forms preferred • Familiarity with commercial manufacturing and supply support preferred • Prior people leadership or matrix leadership experience preferred

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity