Associate Director, Analytical Development (Biologics)

Xaira Therapeutics
United States
Workplace: OnsiteFull timeFunction: Executive & General ManagementEducation: phdSkills: ["Leadership","Collaboration","Project management","Regulatory readiness","External coordination"]

Lead analytical development activities for biologics from preclinical to clinical stages. Oversee method development, validation, transfer, and stability programs; manage external labs; ensure analytical strategies align with CMC development, regulatory expectations, and program needs; contribute to regulatory submissions and cross-functional program execution.

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FursaFursa
Xaira Therapeutics
Xaira Therapeutics
2 months ago

Associate Director, Analytical Development (Biologics)

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Source: Company careers pageValidated by: Fursa AI
Last checked: 10 hours agoStatus: Live

Job Summary

Lead analytical development activities for biologics from preclinical to clinical stages. Oversee method development, validation, transfer, and stability programs; manage external labs; ensure analytical strategies align with CMC development, regulatory expectations, and program needs; contribute to regulatory submissions and cross-functional program execution.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Lead the development, qualification, validation, and transfer of analytical methods across the product lifecycle for biologics programs.
  • •Support the selection and oversight of contract development and manufacturing organizations, and contract laboratories.
  • •Provide technical oversight for analytical methods supporting reference standards, starting materials, intermediates, release testing, stability testing, drug substance, and drug product.
  • •Manage analytical activities performed by external contract laboratories, ensuring scientific rigor, technical alignment, and compliance with applicable quality standards.
  • •Develop and implement analytical strategies appropriate for each stage of CMC development and consistent with evolving regulatory expectations.

Key Requirements

  • •PhD in analytical chemistry or related discipline with 8+ years of industry experience, or BS/MS with 15+ years of industry experience
Experience:BiotechBiopharmaceuticalCMCAnalytical development
Education:PhD / Doctorate
Skills:LeadershipCollaborationProject managementRegulatory readinessExternal coordination
Languages:English
Tech Stack:HPLCUHPLCLC-MSSECRPIEXCE-SDSIcIEFBinding assaysPotency assaysHCPDNAProtein A

Company Brief

Xaira Therapeutics
Xaira Therapeutics is a biotechnology company developing novel targeted therapeutics using proprietary discovery platforms to address serious unmet medical needs. The company focuses on advancing preclinical and clinical-stage programs toward regulatory approval and commercialization.
Industry: Biotech
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