Director / Senior Director, Technical Operations

ARS Pharmaceuticals•San Diego, CA

About The Position

ARS Pharmaceuticals is seeking a Director / Senior Director, Technical Operations to provide strategic leadership for external manufacturing and Technical Operations activities supporting the development, lifecycle management, and commercial supply of neffy®. The role is accountable for manufacturing strategy, contract manufacturing organization (CMO) performance, process and technology lifecycle management, resolution of major technical issues, and execution of Technical Operations initiatives across ARS’s outsourced manufacturing network. The successful candidate will bring technical, business, and operational leadership, cross-functional influence, and CMO management expertise to support manufacturing excellence, scalable operations, and reliable product supply. The role leads complex cross-functional programs and external partner relationships; oversees partner performance and agreements; manages departmental planning and budgets; and ensures technical, supply, regulatory, and business risks are identified, assessed, and escalated. It provides technical oversight across development, scale-up, technology transfer, validation, clinical and commercial manufacturing, investigations, changes, and manufacturing lifecycle management. The position also provides leadership for commercial supply operations, serialization, distribution, and clinical supply activities. The position requires a bachelor’s degree in a relevant scientific or technical discipline, or an acceptable combination of education and relevant experience, and at least 10 years of relevant pharmaceutical or biotechnology experience. An advanced degree is preferred. Extensive experience managing external CMOs/CDMOs and supporting GMP clinical and commercial manufacturing is required. Travel domestically and internationally may be required up to approximately 25%.

Requirements

Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or a related scientific/technical discipline, or an acceptable combination of education and relevant experience.
At least 10 years of relevant pharmaceutical or biotechnology experience in Technical Operations, manufacturing, process development, CMC, or related functions, including demonstrated leadership of complex programs and external manufacturing relationships.
Significant experience managing external CMOs/CDMOs in an outsourced operating model and supporting GMP clinical and commercial manufacturing.
Broad knowledge of cGMP, pharmaceutical manufacturing, quality systems, formulation and process development, scale-up, technology transfer, process validation, lifecycle management, and applicable CMC regulatory expectations.
Demonstrated ability to lead outsourced manufacturing relationships, complex cross-functional programs, and teams, including governance, performance management, contract/scope management, budgeting, executive-level escalation, influence without direct authority, and partner accountability.
Strong strategic, analytical, and problem-solving skills, including the ability to evaluate complex technical and business issues and balance risk, cost, supply continuity, and regulatory considerations.
Excellent written, verbal, negotiation, and presentation skills, with ability to influence across functions and organizational levels and communicate with senior management and external partners.
Strong business and financial acumen, including ability to translate budgets, forecasts, manufacturing costs, contract terms, and operational metrics into business decisions and actions.
Experience establishing scalable Technical Operations processes and systems; proficiency with Microsoft Office and relevant project, reporting, or data-management tools.
Knowledge of outsourced commercial and clinical supply operations, including 3PL management, serialization/EPCIS and DSCSA compliance, and clinical supply/IRT/IWRS processes.
Ability to travel domestically and internationally up to approximately 25%.

Nice To Haves

An advanced degree (MS, PhD, or MBA).
Experience with drug-device combination products, nasal or inhalation products, sterile manufacturing, process validation/PPQ, commercial product launch, and lifecycle management.
Experience supporting CMC regulatory strategy and submissions, major investigations and change controls, vendor/supply agreements, budget planning, and business continuity.
Prior people-management or functional leadership experience.
Experience overseeing commercial distribution and 3PL partners, serialization/EPCIS and DSCSA compliance, and clinical supply operations including IRT/IWRS; experience across multiple of these areas is preferred.

Responsibilities

Provide leadership for Technical Operations programs and external manufacturing activities, setting strategy, priorities, scope, timelines, deliverables, responsibilities, budgets, risks, and decision points.
Own senior-level relationships with key CMOs/CDMOs and other external partners; establish governance, performance expectations, escalation pathways, and accountability for delivery.
Lead technical activities related to 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 with external manufacturers and internal stakeholders, including support for critical campaigns, product launches, and supply requirements.
Review and oversee manufacturing and process documentation, process performance, vendor changes, investigations, product reviews, deviations, out-of-specification or atypical results, and complex manufacturing problems; ensure robust investigation, root-cause analysis, corrective and preventive actions, and continued process control in partnership with Quality Assurance.
Lead technical assessments of significant manufacturing, process, component, and supplier changes, coordinating evaluation of quality, regulatory, supply, financial, and business impacts.
Establish and review manufacturing, supply, and partner performance metrics and KPIs; drive lifecycle improvements, operational excellence, capacity planning, cost improvement, and risk reduction.
Lead external partner governance and development, including partner selection, business reviews, scopes of work, proposals, change orders, contract and supply agreement support, and escalation of commercial or operational issues.
Develop business continuity, capacity, and second-source strategies for critical manufacturing capabilities and materials.
Represent Technical Operations on cross-functional program and leadership teams; communicate strategy, status, risks, financial implications, and recommendations to senior management and stakeholders.
Partner with Regulatory Affairs on CMC strategy, regulatory submissions, post-approval changes, and health authority responses, ensuring manufacturing plans and technical decisions align with regulatory commitments.
Lead Technical Operations business planning and continuous improvement, including departmental budget development with Finance/FP&A, contract lifecycle management, process standardization, and long-range manufacturing planning.
Provide leadership and governance for commercial supply operations, including 3PL and distribution partner performance, inventory and supply continuity, shipping and returns interfaces, product launches, and new markets.
Oversee the commercial serialization program, including serialized packaging, EPCIS data exchange, and compliance with applicable DSCSA requirements; ensure issues are escalated and resolved cross-functionally.
Lead clinical supply operations, including clinical material planning, packaging, labeling, distribution, inventory and expiry management, and coordination of IRT/IWRS activities with Clinical Operations and external vendors.
Travel domestically and internationally up to approximately 25% to support external manufacturing partners, governance meetings, and key manufacturing activities.