Associate Director, Material Science

🕒 Julho 2

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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

• Lead scientific strategic leadership for small molecule drug development programs • Ensure robust solid-state form selection, particle and material control strategies, and successful technology transfer • Contribute and execute material science strategy for small molecule drug substance and drug product programs • Serve as subject matter expert in solid-state chemistry, physicochemical characterization, and structure–property–process relationships • Design, interpret, and oversee material characterization using techniques such as XRPD, DSC, TGA, DVS, spectroscopy, microscopy, and particle size analysis • Lead early material risk assessments and mitigation strategies • Support prototype formulation development and transfer of material knowledge from discovery to development and clinical manufacturing teams • Author, review, and approve NDA/MAA CMC sections related to materials, solid-state control, and lifecycle management • Identify, assess, and mitigate material-related risks during scale-up and validation

🎯 Requisitos

• PhD in Materials Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field or MS with substantial relevant industry experience • Typically 8–12+ years of experience in pharmaceutical or biotech drug development, with a strong focus on small molecule programs • Demonstrated experience supporting oral solid dosage forms (preferred) • Proven track record contributing to IND and NDA submissions • Experience with technology transfer and commercial manufacturing (internal or CMOs) • Strong written and verbal communication skills, including regulatory technical writing • Ability to lead without authority and influence cross-functional teams • Strategic thinker with strong problem-solving and decision-making 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