Dir​/Sr. Director, Downstream Biologics Manufacturing

Chesterbrook, PA

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.

The Dir./Sr. Director, Downstream Biologics Manufacturing will provide technical and strategic leadership for outsourced downstream drug substance manufacturing, with primary responsibility for supporting late-stage clinical development and advancing biologics manufacturing processes toward commercial readiness. This individual will serve as the Company's downstream manufacturing subject matter expert and primary technical representative with Contract Development and Manufacturing Organizations (CDMOs/CMOs), ensuring reliable clinical supply while driving manufacturing execution, process characterization, technology transfer, process validation/PPQ, regulatory readiness, and preparation for commercial manufacturing.

The Dir./Sr. Director will partner closely with internal and consultant CMC resources, Quality, Regulatory Affairs, Analytical Development, Supply Chain, Program Management, and external manufacturing partners to ensure robust, compliant, scalable, and reliable production of biologic drug substance. The role requires strong technical judgment, ownership, and the ability to influence and drive results in a highly outsourced operating model.

• Provide technical leadership for downstream drug substance manufacturing supporting all phases of clinical development with a primary focus on Phase 3 and progression toward commercial manufacturing.
• Drive downstream manufacturing readiness for clinical supply, process validation/PPQ, regulatory submissions, and commercial launch.
• Lead downstream process characterization and validation strategy, including assessment of critical process parameters (CPPs), their relationship to critical quality attributes (CQAs), process robustness, impurity clearance, and development of an appropriate commercial control strategy.
• Provide technical oversight during engineering, demonstration, PPQ, validation, and other late-stage manufacturing batches.
• Assess manufacturing and process changes for potential product quality, yields, comparability, validation, and regulatory impact in partnership with Analytical, Quality, and Regulatory CMC.

• Serve as the technical lead and Company subject matter expert for downstream manufacturing activities performed at external CDMOs.
• Lead the technical evaluation, selection, qualification, governance, and ongoing performance management of downstream CDMO partners.
• Provide technical oversight of downstream purification processes, including harvest clarification, chromatography, viral inactivation and clearance, filtration, ultrafiltration/diafiltration (UF/DF), concentration, and bulk drug substance operations.
• Review manufacturing readiness, campaign plans, batch records, production schedules, process performance, and manufacturing data to ensure successful execution.
• Establish strong technical relationships with CDMO process development, manufacturing, quality, engineering, and project management teams; appropriately challenge and elevate technical or execution risks.
• Provide technical input to scopes of work, manufacturing agreements, change orders, and contract discussions related to process requirements and CDMO capabilities.

• Review and assess batch records, process trends, deviations, investigations, and manufacturing performance data.
• Lead technical troubleshooting during manufacturing campaigns and drive or support root-cause investigations for process deviations, non-conformances, and unexpected manufacturing performance.
• Evaluate downstream process performance, including step yields, chromatography performance, impurity clearance, viral clearance, filtration performance, product recovery, product quality, and process consistency.
• Identify and oversee implement appropriate process improvements while maintaining alignment with late-stage development, comparability, validation, and regulatory requirements.
• Working with CDMO’s evaluate resin, membrane, filter, buffer, raw material, and equipment considerations that may impact process robustness, scalability, supply continuity, or commercial readiness.

• Lead downstream technology transfers between development laboratories,…