Associate Director, Drug Product & Process Development – Small Molecules

🕒 July 2

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 6%

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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 late ‑ stage drug product development activities (Phase 2/3 through commercial launch) • 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 • 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 • Support Health Authority interactions (FDA, EMA, etc.) • Lead and support post ‑ approval lifecycle management activities • Act as a technical representative on cross ‑ functional program teams

🎯 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 (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

🏖️ 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 • Other company provided benefits