Director, Drug Product & Process Development – Small Molecules

🕒 Julho 1

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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 late-stage development of oral solid dosage forms (e.g., IR, MR, XR and complex formulations) • Finalize commercial formulations and manufacturing processes including blending, granulation, compression, coating, and encapsulation • Ensure drug product design is robust, scalable, and aligned with registration and commercial manufacturing requirements • Support scale‑up activities and ensure consistency between clinical, registration, and commercial processes • Conduct and document risk assessments for CQAs and CPPs; implement mitigation strategies as needed • Lead execution of drug product CMC activities for NDA submission for assigned programs • Author, review, and approve NDA Module 3 sections related to oral solid dosage form development, manufacturing, and controls • Support responses to FDA and health authority information requests during NDA review • Participate in regulatory meetings and contribute to pre‑approval inspection (PAI) readiness activities • Lead or support process characterization studies and PPQ activities for OSD products • Support continued process verification planning in collaboration with Quality and Manufacturing • Execute technology transfer of oral solid dosage form processes to commercial manufacturing sites or CDMOs • Troubleshoot late‑stage manufacturing and scale‑up issues related to OSD unit operations • Provide day‑to‑day technical oversight of CDMOs manufacturing oral solid dosage forms • Review development reports, batch records, and validation documentation from external partners • Work with Quality and Supply Chain to support launch readiness and reliable supply • Serve as the drug product CMC representative on late‑stage program teams • Collaborate closely with Drug Substance, Analytical Development, Regulatory Affairs, Quality, Manufacturing, and Program Management • Communicate development risks, timelines, and mitigation plans to functional and program leadership • Lead and mentor a small team of scientists and engineers supporting oral solid dosage form development • Provide technical guidance, performance feedback, and development coaching • Manage project‑level budgets, outsourcing activities, and timelines for assigned programs • Support post‑approval change management activities including comparability assessments and CBE submissions • Contribute to continuous improvement initiatives focused on process robustness, manufacturability, and cost‑of‑goods • Provide ongoing technical support for commercial oral solid dosage form products as needed

🎯 Requisitos

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline • 10–12+ years of experience in oral solid dosage form drug product and process development • Demonstrated experience supporting late‑stage development and at least one NDA submission • Experience supporting FDA inspections or PAI readiness for OSD manufacturing sites • Hands‑on experience working with CDMOs and commercial manufacturing environments • Strong expertise in OSD formulation and unit operations • Working knowledge of QbD principles, control strategies, process validation, and lifecycle management • Experience addressing common OSD challenges such as content uniformity, dissolution performance, and scale‑up risks

🏖️ 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 as well as other company provided benefits