Associate Director, Analytical Development

BioCryst Pharmaceuticals, Inc.

. Provide scientific and operational leadership for analytical development across biologics programs from early development through late stage and commercialization, primarily at external partners .

Posted 9/21/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in analytical development for biologics, including method development, validation, and regulatory submissions. Proven ability to lead cross-functional teams and manage external partnerships while ensuring compliance with quality standards.

Highest-signal resume keywords

PhD In Chemistry Or BiochemistryAnalytical Development For BiologicsRegulatory Submissions ExperienceMethod Development And ValidationStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Method DevelopmentPotency AssaysImpurities AssaysGMP Release TestingStability TestingData InterpretationControl StrategiesCharacterization PackagesQuality ControlLifecycle Management

Soft Skills

LeadershipMentorshipCoachingRelationship ManagementCommunication

Industry Keywords

Biologics ProgramsCDMOCTLCMC Regulatory StrategiesQuality AssuranceFast-Paced Biotech EnvironmentTechnical ReportsRegulatory DocumentationCAPA ActivitiesOOS/OOT Investigations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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