Xaira Therapeutics

4 weeks ago

Associate Director, Analytical Development (Biologics)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 8 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

Website

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Xaira Therapeutics

4 weeks ago

Associate Director, Analytical Development (Biologics)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 8 hours agoStatus: Live

Job Summary

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

Industry: Biotech

Website