Director Analytical Development

At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.

We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.

P osition

Summary:

The Director, Analytical Development will provide technical and strategic leadership for analytical development, characterization, method lifecycle management, and testing strategies supporting the Company's biologics programs, with primary responsibility for supporting late-stage clinical development and advancing programs toward commercial readiness. This individual will serve as the Company's analytical development subject matter expert and primary technical representative with external laboratories, Contract Development and Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs), supporting all phases of clinical development with a focus on Phase 3 clinical supply, process characterization and validation, comparability, specifications, stability, method qualification/validation and transfer, regulatory submissions, PPQ, and preparation for commercial manufacturing.

The Director will partner closely with Upstream and Downstream Manufacturing, Quality, Regulatory Affairs, Supply Chain,Program Management, and external analytical and QC partners to ensure analytical methods and control strategies are scientifically sound, phase-appropriate, compliant, robust, and suitable for commercialization. The role requires strong scientific judgment, ownership, and the ability to influence and drive results in a lean, highly outsourced operating model.

ESSENTIAL DUTIES AND RSPONSIBILITIES:

• Provide technical and strategic leadership for analytical development activities supporting all phases of clinical development and progression toward commercial manufacturing.
• Develop and execute analytical strategies generating and implementing new specifications, supporting clinical supply, process characterization, PPQ/process validation, regulatory submissions, and commercial launch.
• Lead development and implementation of phase-appropriate analytical control strategies for biologic drug substance and drug product.
• Drive analytical method development, optimization, qualification, validation, transfer, and lifecycle management.
• Ensure analytical methods are appropriate for their intended use and capable of supporting product release, stability, characterization, comparability, and process validation activities.
• Partner with Quality and Regulatory CMC to establish and justify appropriate specifications for drug substance, drug product, intermediates, and other relevant materials.
• Provide analytical leadership supporting PPQ and commercial readiness activities.

• Lead analytical characterization strategies to establish and maintain comprehensive understanding of product quality attributes.
• Develop and oversee analytical approaches for evaluating identity, purity, contamination, potency, strength, charge variants, size variants/aggregates, glycosylation, post-translational modifications, and process- and product-related impurities, as applicable.
• Partner with Process Development and Manufacturing to establish relationships between process parameters and critical quality attributes (CQAs).
• Lead analytical strategies supporting comparability assessments associated with manufacturing process, scale, site, formulation, raw material, or other changes.
• Ensure appropriate use of orthogonal analytical methods to characterize product structure, function, purity, and biological activity.
• Evaluate analytical data and product quality trends to identify potential risks or changes in product performance.

• Serve as the Company's analytical technical lead and subject matter expert with external testing laboratories, CROs, and CDMOs.
• Lead technical evaluation, selection, qualification, governance, and ongoing performance management of analytical partners.
• Oversee…