Associate Director, Drug Product & Process Development – Small Molecules

🕒 Julho 2

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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