Associate Director, Analytical Development (Biologics)

About the role

The Associate Director, Analytical Development (Biologics) will lead analytical development activities supporting biologics programs from preclinical development through clinical execution. This role will oversee method development, validation, transfer, stability programs, and external laboratory activities, while ensuring analytical strategies are aligned with program needs, phase-appropriate CMC development, and regulatory expectations.

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.
• Author and provide technical review of relevant CMC sections for regulatory submissions, including INDs, IMPDs, BLAs, MAAs, and related filings.
• Design and manage non-GMP and cGMP stability programs for drug substance and drug product batches, providing scientific guidance to support shelf-life and expiry dating recommendations.
• Partner cross-functionally with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and external partners to ensure analytical plans are integrated with overall program objectives.
• Provide analytical expertise in support of out-of-specification results, deviations, non-conformance investigations, root cause analyses, and CAPA development.
• Serve as a key member of the CMC and Technical Operations team, contributing to cross-functional execution, continuous improvement, and a strong quality culture.

Requirements

• PhD in analytical chemistry or related discipline with more than 8 years of industry experience or BS/MS degree with more than 15 years industry experience
• Demonstrated experience in analytical development, method validation, method transfer, and molecular stability management within a regulated biopharmaceutical or pharmaceutical environment.
• Strong working knowledge of biologics CMC development, including complex modalities such as multi-specifics, as well as cGMP expectations, quality systems, and regulatory submission requirements.
• Experience managing external consultants, contract laboratories, CMOs, or CDMOs, with a proven ability to drive technical alignment across internal and external stakeholders.
• Experience supporting biologics, protein therapeutics, or other complex modalities from early development through clinical-stage execution.
• Track record of authoring or reviewing CMC content for IND, IMPD, BLA, MAA, or related regulatory submissions.
• Success Profile

Benefits

Additional Information

About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and antibody therapeutics, enabling the creation of medicines against historically hard-to-drug molecular targets. It is also developing foundation models for biology and disease to enable better target elucidation and patient stratification. Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development. Xaira is headquartered in the San Francisco Bay Area, Seattle, and London.

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