Director, Drug Product Development

🕒 Julho 15

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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BioCryst Pharmaceuticals, Inc.

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501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals em 2023-04

Healthcare • Consulting • Logistics

A BioCryst Pharmaceuticals, Inc. é uma empresa global de biotecnologia focada na descoberta, desenvolvimento e comercialização de novos tratamentos orais com pequenas moléculas e proteínas para doenças raras, notadamente o angioedema hereditário (AEH). Fundada em 1986, a BioCryst utiliza design de medicamentos guiado por estrutura, química medicinal e tecnologias avançadas para desenvolver medicamentos de primeira classe ou superiores, e trabalha em estreita colaboração com pacientes, grupos de apoio e parceiros globais para levar os tratamentos ao mercado.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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