Associate Director, Drug Product & Process Development – Small Molecules

🕒 il y a 26 jours

🇺🇸 États-Unis – Télétravail

💵 $169 222 - $253 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

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Otsuka Pharmaceutical Companies (U.S.)

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1001 - 5000 employés

💊 Pharmaceutique

🏥 Santé

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.

Description

• Provide technical and strategic leadership for late-stage drug product development programs • Lead Phase 2/3 through commercial-launch activities, including formulation optimization, process validation readiness, and robustness studies • Provide technical oversight for manufacturing processes, scale-up, tech transfer, PPQ, and commercial manufacturing support • Ensure development strategies align with Quality by Design principles and defined CMAs, CPPs, and control strategies • Author and review technical development plans, process descriptions, development reports, and validation summaries • Serve as CMC drug product lead for NDA and/or MAA filings, including Modules 2.3 and 3 • Support FDA, EMA, and other Health Authority interactions, including information requests, deficiency responses, and commitment fulfillment • Lead and support post-approval lifecycle management activities, including formulation changes, site transfers, process improvements, specification updates, and alternate sourcing • Assess change impact and support regulatory submissions such as PAS, CBE-30, annual reports, and variations • Drive continuous improvement to enhance process robustness, manufacturability, and supply reliability • Represent drug product technical development on cross-functional program teams • Provide technical direction to CMOs/CDMOs • Mentor junior scientists and engineers and contribute to organizational CMC capabilities

🎯 Exigences

• 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 from Phase 3 to commercial • Direct involvement in NDA or equivalent CMC submissions, including authorship and regulatory agency interactions • 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 lifecycle management strategies and post-approval changes • Excellent technical writing, communication, and cross-functional collaboration skills • Experience with external manufacturing partners (CDMOs) preferred • Experience with aseptic, solid oral, or other relevant dosage forms preferred • Familiarity with commercial manufacturing and supply support preferred • Prior people leadership or matrix leadership experience preferred

🏖️ Avantages

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity

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