Associate Director, Drug Product & Process Development – Small Molecules

🕒 July 2

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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