Associate Director, Analytical Development

🕒 Setembro 21

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 10%

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BioCryst Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

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

• Provide scientific and operational leadership for analytical development across biologics programs from early development through late stage and commercialization, primarily at external partners • Lead analytical strategies for potency, impurities, and other release assays supporting biologics development, clinical supply, late-stage development, and commercialization readiness • Interpret and apply product quality data to define CQAs, QTPPs, control strategies, and characterization packages supporting regulatory submissions and process changes • Lead analytical method development, qualification, and testing activities at CDMOs and contract test laboratories • Author and review analytical reports, technical summaries, and other product development documentation • Author and review analytical sections of CMC regulatory filings and communicate analytical risks, timelines, and data interpretations • Build and maintain relationships with CDMO and CTL partners, applying metrics to manage risk, prioritize work, and drive continuous improvement • Stay current with evolving CMC and global regulatory strategies for biologics and small-molecule programs • Provide mentorship, coaching, and leadership to internal and matrixed teams • Partner with QC and Quality stakeholders on method validations, method transfer, reference material qualification, deviation and OOS/OOT investigations, CAPA activities, and lifecycle management • Perform other duties as assigned

🎯 Requisitos

• PhD in Chemistry, Biochemistry, or a related field with 8–12 years of experience in analytical development and QC supporting biologics programs from preclinical through late-stage development • BS/MS with 10–12 years of relevant industry experience in analytical laboratories supporting biologics development and manufacturing • Strong technical expertise in biologics analytical sciences, including potency and impurities assays, life-cycle management methods, and data interpretation • Demonstrated experience supporting regulatory submissions and interacting with Quality and Regulatory functions • Proven ability to manage external partners and deliver results in a fast-paced biotech environment • Excellent written and verbal communication skills, including experience authoring technical reports and regulatory documentation • Experience with method development, validation, transfer, and GMP release and stability testing of biologics, including potency and impurities assays, is required

🏖️ Benefícios

• Equal employment opportunity commitment • Protected Veterans/Individuals with Disabilities employer status