Head of Development Management

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: Late-Stage Analytical Development and Commercial Readiness 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. 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. Analytical Characterization and Product Understanding Lead analytical characterization strategies to establish and maintain comprehensive understanding of product quality attributes. 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. External Laboratory, CRO, and CDMO Leadership 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 outsourced analytical development, method validation, method transfer, characterization, Quality control release, and stability testing activities. Establish strong technical relationships with external analytical development, QC, manufacturing, quality, and project management teams; appropriately challenge and elevate analytical, quality, timeline, or execution risks. Analytical Method Development, Validation, Transfer, and Lifecycle Management Lead development, optimization, qualification, and validation of analytical methods supporting biologic drug substance and drug product. Lead analytical method transfers between development laboratories, CROs, CDMOs, QC laboratories, and commercial testing sites. Monitor method performance following transfer and validation and identify opportunities for appropriate method improvements. Develop and maintain analytical method lifecycle strategies supporting late-stage development through commercialization. Stability and Specification Strategy Provide technical leadership for stability strategies supporting clinical development, regulatory submissions, and commercialization. Partner with Quality and Regulatory CMC to develop scientifically justified specifications and acceptance criteria. Review and interpret stability data, generate trends, support excursions, and out-of-specification or out-of-trend results. Ensure stability programs appropriately support regulatory filing and commercial requirements. Analytical Troubleshooting and Investigations Provide technical leadership for analytical investigations, including OOS, OOT, atypical results, method performance issues, and laboratory deviations. Lead or support root-cause investigations and development of scientifically sound corrective and preventive actions. Evaluate analytical trends and method performance to proactively identify potential risks. Partner with Quality, Manufacturing, and external laboratories to ensure timely investigation and resolution of analytical issues that could impact clinical supply or program timelines. Assess analytical changes for potential comparability, validation, product quality, and regulatory impact. Quality and Regulatory Leadership Ensure analytical development activities comply with applicable cGMP, ICH, FDA, EMA, pharmacopeial, and internal quality requirements. Provide technical review and approval, as appropriate, of analytical methods, validation protocols and reports, specifications, stability protocols, investigations, change controls, CAPAs, risk assessments, and technical reports. Serve as the analytical development SME for regulatory submissions and health authority interactions. Lead or contribute to preparation and review of relevant IND/IMPD/BLA/MAA CMC analytical sections, including analytical procedures, method validation, specifications, characterization, stability, and comparability content. Support regulatory inspections, partner audits, and pre-approval inspection readiness for analytical activities. Cross-Functional CMC Leadership and Risk Management Partner closely with Upstream and Downstream Manufacturing to ensure analytical strategies appropriately support process development, process characterization, technology transfer, manufacturing investigations, and PPQ. Collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Process Development, Supply Chain, and CMC leadership to advance program objectives. Proactively identify analytical, testing capacity, method, reference standard, stability, vendor, and regulatory risks that could impact Phase 3 clinical supply or commercial readiness; Provide clear scientific assessments, risk evaluations, recommendations, and decision options to CMC and senior management. Track key analytical deliverables, timelines, risks, and external partner performance and ensure timely escalation and resolution of issues. S. in Analytical Chemistry, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, Biology, or a related scientific discipline. 10+ years of progressive biopharmaceutical industry experience in analytical development, characterization, Quality Control, and/or CMC development; Demonstrated experience supporting late-stage biologics development, including Phase 3 programs and progression toward regulatory filing and commercial readiness. Demonstrated experience with analytical method development, qualification, validation, transfer, and lifecycle management. Demonstrated experience managing analytical activities at external CROs, CDMOs, and/or testing laboratories. Working knowledge of ICH, FDA, EMA, cGMP, and biologics analytical regulatory requirements. Technical Expertise Analytical method development, qualification, validation, transfer, and lifecycle management. Chromatographic methods including HPLC/UPLC, SEC, ion-exchange chromatography, and reversed-phase chromatography. Mass spectrometry and other structural characterization methodologies. Protein concentration, identity, purity, and impurity testing. Aggregate and size-variant analysis; charge-variant analysis; Process- and product-related impurity testing, including host cell protein and residual DNA, as applicable. Stability-indicating methods and stability data interpretation. specification development and justification. Strong scientific and technical leadership with sound analytical judgment. Ability to integrate complex analytical data into clear conclusions and development recommendations. Strategic thinking with the ability to anticipate analytical and regulatory risks. Strong ownership, accountability, and action orientation in a lean, highly outsourced biotech environment. Excellent problem-solving, root-cause analysis, and decision-making skills. Strong cross-functional collaboration and project leadership. Ability to communicate complex scientific issues, risks, options, and recommendations clearly to technical and executive audiences. Strong regulatory, quality, and inspection-readiness mindset. Experience supporting successful PPQ campaigns, pre-approval inspection readiness, and transition to commercial manufacturing. Experience establishing late-stage and commercial specifications for biologic drug substance and drug product. Experience developing analytical comparability strategies supporting manufacturing process, scale, or site changes. Experience with potency assay development, qualification, validation, and lifecycle management for biologics. Experience supporting analytical activities across multiple global CRO/CDMO/testing sites. Experience with electronic laboratory systems, LIMS, digital data management, and analytical data platforms. Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office. Travel: This position requires up to 30% domestic and internation travel. Avalo is pursuing additional development opportunities in IL-1β driven indications. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e‑mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.

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