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 Manager / Sr. Manager, Technical Operations will play a key role in executing Technical Operations programs that support the continued development and commercial supply of neffy™. The successful candidate will combine strong technical judgment, project management, and external partner leadership in a highly collaborative environment.

Working closely with internal stakeholders and CMOs, this role provides technical and operational leadership across the ARS outsourced manufacturing network. Responsibilities include leading Technical Operations projects, supporting formulation and process development, technology transfer, GMP manufacturing activities, and resolution of technical and operational issues. The position ensures project scope, timelines, deliverables, responsibilities, and budgets remain aligned while proactively identifying and escalating risks to support compliant, reliable, and on-time product supply.

ESSENTIAL DUTIES & RESPONSIBILITIES

Manage cross-functional Technical Operations projects and day-to-day technical and operational interactions with assigned external partners, including scope, timelines, deliverables, responsibilities, budgets, risks, key milestones, project meetings, action tracking, scopes of work, proposals, change orders, and CMO/vendor performance metrics and KPIs (e.g., service, quality, delivery, capacity, and right-first-time).
Serve as a Technical Operations point of contact for assigned external manufacturing partners and work closely with CMOs and internal stakeholders to ensure execution against agreed project plans and supply requirements.
Provide technical oversight of formulation and process development, scale-up, technology transfer, process characterization, process validation/PPQ, and continued process verification activities, as applicable.
Plan and support clinical and commercial manufacturing campaigns in coordination with CMOs, Supply Chain, Quality Assurance, and other internal functions; provide on-site/person-in-plant support for key manufacturing activities as needed.
Review manufacturing and process documentation, including master and executed batch records, protocols, reports, process performance data, vendor change controls, investigations, and annual/product reviews, for technical accuracy and process performance.
Lead or support technical assessment and resolution of manufacturing deviations, out-of-specification or atypical results, and other process issues; contribute to root-cause analysis and appropriate corrective and preventive actions in partnership with Quality Assurance.
Assess proposed manufacturing and process changes for technical impact and support cross-functional evaluation of quality, supply, and regulatory implications.
Monitor and trend manufacturing and process performance data to identify emerging risks, process drift, and opportunities for continuous improvement and operational excellence.
Support vendor selection, onboarding, and qualification activities in collaboration with Quality Assurance, Supply Chain, Procurement, and other stakeholders.
Communicate project status, technical risks, manufacturing issues, and recommend actions clearly to Technical Operations leadership and cross-functional stakeholders; escalate significant issues to appropriate decision-makers.
Support preparation and review of CMC information for regulatory submissions and responses to health authority questions, as required.
Support Technical Operations process improvement, business continuity, capacity planning, and other strategic operational initiatives as assigned.
Support commercial supply operations managed within Technical Operations, including coordination with third-party logistics (3PL) providers, distribution partners, and external manufacturing/packaging partners to maintain reliable product supply.