Manager / Senior Manager, Technical Operations

ARS Pharmaceuticals•San Diego, CA

About The Position

The Manager / Senior Manager, Technical Operations will execute Technical Operations programs supporting the continued development and commercial supply of neffy®. The role provides technical and operational leadership across ARS Pharmaceuticals’ outsourced manufacturing network, working closely with internal stakeholders and contract manufacturing organizations (CMOs). Responsibilities span technical project leadership, formulation and process development, technology transfer, GMP manufacturing, 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. The position also supports commercial supply operations, including coordination with third-party logistics providers, distribution partners, and external manufacturing and packaging partners. It supports product serialization, EPCIS data exchange, and operational compliance with applicable DSCSA requirements, as well as clinical supply activities such as packaging, labeling, distribution, inventory and expiry management, and IRT/IWRS activities. Domestic and international travel of up to approximately 20% is required to support external manufacturing partners and key project activities.

Requirements

Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or a related scientific or technical discipline; an acceptable combination of education and relevant experience will also be considered.
At least 5 years of relevant pharmaceutical or biotechnology experience in Technical Operations, manufacturing, process/formulation development, CMC, supply chain, or a related function.
Strong working knowledge of cGMP, pharmaceutical manufacturing operations, and applicable quality systems and regulatory expectations.
Technical understanding of formulation, manufacturing processes, scale-up, technology transfer, process validation, and process performance sufficient to evaluate CMO data and recommendations, work effectively on cross-functional technical teams, and hold external partners accountable.
Strong project and vendor management skills, including the ability to manage multiple priorities, timelines, deliverables, and external partners in a fast-paced environment.
Strong analytical and problem-solving skills, including the ability to evaluate complex manufacturing or process issues, develop recommendations, and communicate the rationale for action.
Excellent written, verbal, and presentation skills, with the ability to communicate across functions and organizational levels, including senior management and external partners.
Well-organized and detail-oriented, with the ability to identify and escalate risks while maintaining focus on execution and business priorities.
Proficiency with Microsoft Office and project/reporting tools.
Must be able to travel domestically and internationally up to approximately 20%.

Nice To Haves

An advanced degree in a relevant discipline.
Experience working with external CMOs/CDMOs and supporting GMP clinical and/or commercial manufacturing.
Experience with drug-device combination products, nasal/inhalation products, sterile manufacturing, commercial product launch, or PPQ.
Experience reviewing manufacturing batch records and process documentation and supporting technical investigations, change controls, and regulatory CMC activities.
Experience supporting commercial distribution/3PL operations, serialization/EPCIS and DSCSA compliance, and/or clinical supply and IRT/IWRS activities.
Direct experience in one or more commercial or clinical supply operations areas, including 3PL interfaces, serialization/EPCIS and DSCSA requirements, or clinical IRT/IWRS processes.
Experience with project management, continuous improvement, or operational excellence methodologies.

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, milestones, meetings, action tracking, scopes of work, proposals, change orders, and vendor performance metrics and KPIs.
Serve as a Technical Operations point of contact for assigned external manufacturing partners and coordinate with CMOs and internal stakeholders to execute project plans and meet supply requirements.
Provide technical oversight of formulation and process development, scale-up, technology transfer, process characterization, process validation/PPQ, and continued process verification, as applicable.
Plan and support clinical and commercial manufacturing campaigns 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.
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 corrective and preventive actions 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 with Quality Assurance, Supply Chain, Procurement, and other stakeholders.
Communicate project status, technical risks, manufacturing issues, and recommended actions to Technical Operations leadership and cross-functional stakeholders; escalate significant issues to 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.
Support commercial supply operations, coordinating with 3PL providers, distribution partners, and external manufacturing and packaging partners to maintain reliable product supply.
Support product serialization activities, including EPCIS data exchange and operational compliance with applicable DSCSA requirements, in coordination with packaging, distribution, Quality Assurance, and other partners.
Support clinical supply activities, coordinating with Clinical Operations and external vendors on clinical packaging, labeling, distribution, inventory and expiry management, and IRT/IWRS activities, as applicable.
Travel domestically and internationally up to approximately 20% to support external manufacturing partners and key project activities.