Manager / Senior Manager, Technical Operations

ARS Pharmaceuticals Operations, Inc.•San Diego, CA

5d•$140,000 - $175,000

About The Position

ARS Pharmaceuticals is seeking a Manager / Senior Manager, Technical Operations to execute programs supporting the continued development and commercial supply of neffy®. The role combines technical judgment, project management, and external partner leadership in a collaborative environment, providing technical and operational leadership across ARS’s outsourced manufacturing network. The position works closely with internal stakeholders and contract manufacturing organizations (CMOs) on technical operations projects, formulation and process development, technology transfer, GMP manufacturing, and resolution of technical and operational issues. It also maintains alignment on project scope, timelines, deliverables, responsibilities, and budgets, and proactively identifies and escalates risks to support compliant, reliable, and timely product supply. The role supports clinical and commercial manufacturing, manufacturing documentation review, technical investigations, process performance monitoring, vendor qualification, regulatory CMC activities, and commercial and clinical supply operations. It also supports serialization and applicable DSCSA requirements, clinical supply coordination, and operational initiatives. Domestic and international travel of up to approximately 20% is required. The posted full-time salary range is $140,000 to $175,000, with possible eligibility for a discretionary annual performance bonus. The position is also eligible for equity, 401(k) matching, and benefits that include 100% employer-paid medical, dental, and vision coverage for employees. ARS Pharmaceuticals is an equal opportunity employer and provides reasonable accommodation to qualified individuals with disabilities.

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 or formulation development, CMC, supply chain, or a related function.
Strong working knowledge of cGMP, pharmaceutical manufacturing operations, quality systems, and applicable 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 in 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 assess 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.
Ability to travel domestically and internationally up to approximately 20% to support external manufacturing partners and key project activities.

Nice To Haves

An advanced degree.
Experience working with external CMOs/CDMOs and supporting GMP clinical and/or commercial manufacturing.
Experience with drug-device combination products, nasal or 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.
Working knowledge of commercial and clinical supply operations relevant to Technical Operations, including 3PL interfaces, serialization/EPCIS and DSCSA requirements, and 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 project scope, timelines, deliverables, responsibilities, budgets, risks, milestones, meetings, action tracking, scopes of work, proposals, change orders, and vendor performance metrics and KPIs.
Serve as the Technical Operations point of contact for assigned external manufacturing partners and coordinate with CMOs and internal stakeholders to execute agreed 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 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.
Support commercial supply operations, including coordination with third-party logistics providers, distribution partners, and external manufacturing and packaging partners.
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, including coordination with Clinical Operations and external vendors for clinical packaging, labeling, distribution, inventory and expiry management, and IRT/IWRS activities, as applicable.