ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®, the first and only FDA-approved needle-free epinephrine product. If you’re motivated to make a meaningful impact, this is your opportunity to join a collaborative, entrepreneurial, and inclusive culture.

THE OPPORTUNITY

The Director / Senior Director, Technical Operations will provide strategic leadership for ARS' external manufacturing and Technical Operations activities supporting the continued development, lifecycle management, and commercial supply of neffy™. The successful candidate will combine strong technical, business, and operational leadership with cross-functional influence and CMO management expertise to drive manufacturing excellence, scalable operations, and reliable product supply.

This role is accountable for manufacturing strategy, CMO performance, process and technology lifecycle management, resolution of major technical issues, and execution of key Technical Operations initiatives across the ARS outsourced manufacturing network. Working closely with internal stakeholders and external partners, the position leads complex cross-functional programs, oversees partner performance and agreements, manages departmental planning and budgets, and ensures technical, supply, regulatory, and business risks are appropriately identified, assessed, and escalated.

ESSENTIAL DUTIES & RESPONSIBILITIES

Provide leadership for Technical Operations programs and external manufacturing activities, establishing strategy, priorities, scope, timelines, deliverables, responsibilities, budgets, risks, and key decision points.
Own senior-level Technical Operations relationships with key CMOs/CDMOs and other external partners; establish governance, performance expectations, escalation pathways, and accountability for delivery against manufacturing and business commitments.
Provide technical leadership for formulation and process development, scale-up, technology transfer, process characterization, process validation/PPQ, continued process verification, and manufacturing lifecycle management, as applicable.
Oversee clinical and commercial manufacturing strategy and execution in coordination with external manufacturers and internal stakeholders; ensure appropriate Technical Operations support for critical manufacturing campaigns, product launches, and supply requirements.
Provide senior technical review and oversight of manufacturing and process documentation, process performance, significant vendor changes, investigations, annual/product reviews, and significant deviations, out-of-specification or atypical results, and complex manufacturing problems; ensure robust technical investigation, root-cause analysis, effective corrective and preventive actions, continued process control, and reliable manufacturing in partnership with Quality Assurance.
Lead technical assessments of significant manufacturing, process, component, and supplier changes and coordinate evaluation of quality, regulatory, supply, financial, and business impacts with appropriate functional stakeholders.
Establish and review manufacturing, supply, and external partner performance metrics and KPIs, including service, quality, on-time delivery, right-first-time, cost, capacity, and other appropriate measures; drive lifecycle improvements, operational excellence, capacity planning, cost improvement, and risk-reduction initiatives across the external network.
Lead external partner business and technical governance, including selection and strategic development of CMOs, CDMOs, suppliers, and other critical partners; establish performance expectations and governance mechanisms, oversee business reviews, scopes of work, proposals, change orders, contract and supply agreement support, and escalation of commercial or operational issues; and develop business continuity, capacity, and second-source strategies for critical manufacturing capabilities and materials.