Associate Director, Analytical Development

Job not on LinkedIn

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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