Director, Drug Product Development

🕒 il y a 2 mois

🌲 North Carolina – Distant

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⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 19%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of BioCryst Pharmaceuticals, Inc.

BioCryst Pharmaceuticals, Inc.

501 - 1000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €450 000 000 Post-IPO Debt - BioCryst Pharmaceuticals en 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. est une entreprise mondiale de biotechnologie spécialisée dans la découverte, le développement et la commercialisation de nouvelles petites molécules orales et de thérapies protéiques pour les maladies rares, notamment l'œdème angioneurotique héréditaire (OAH). Fondée en 1986, BioCryst utilise la conception de médicaments guidée par la structure, la chimie médicinale et les technologies avancées pour développer des médicaments de première classe ou de meilleure classe, et travaille en étroite collaboration avec les patients, les associations de patients et les partenaires mondiaux pour mettre les traitements sur le marché.

Description

• Lead and direct formulation and process development for patient-centered parenteral drug products supporting BioCryst’s biologics portfolio • Develop drug product development strategies through internal/external partnerships • Drive product development efforts in a phase-appropriate manner • Maintain close collaboration with internal program leaders and stakeholders • Provide subject matter expertise for technical due diligence and regulatory submissions • Author and review high-quality development reports and technical summaries • Mentor and develop colleagues to contribute to a high-performing team

🎯 Exigences

• MS / PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline • At least 10 years of relevant field experience in end-to-end biologics drug product development • Proficient in current approaches for formulation and drug product process development • Experience with high concentration protein formulation development, aseptic processes, vial, prefilled syringe, cartridge presentations • Knowledge of current regulatory guidelines and cGMP requirements • Strong grounding in biochemistry / biophysics • Demonstrated experience supporting regulatory submissions • Proven ability to manage external partners • Excellent written and verbal communication skills

🏖️ Avantages

• Health insurance • Retirement plans • Flexible work arrangements • Professional development opportunities

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