Director / Senior Director, Technical Operations

ARS Pharmaceuticals Operations, Inc.•San Diego, CA

4d•$225,000 - $275,000

About The Position

ARS Pharmaceuticals is seeking a Director / Senior Director, Technical Operations to provide strategic leadership for external manufacturing and Technical Operations supporting the development, lifecycle management, and commercial supply of neffy®. The role combines technical, business, and operational leadership with cross-functional influence and contract manufacturing organization (CMO) management expertise to drive manufacturing excellence, scalable operations, and reliable product supply. The position is accountable for manufacturing strategy, 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 work with internal stakeholders and external partners to lead complex cross-functional programs, oversee partner performance and agreements, manage departmental planning and budgets, and identify, assess, and escalate technical, supply, regulatory, and business risks. This role also provides leadership and governance for commercial supply operations, serialization, and clinical supply operations. It represents Technical Operations on program and leadership teams and partners with Regulatory Affairs on CMC strategy, submissions, post-approval changes, and health authority responses. Domestic and international travel of approximately 25% is required.

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 may also be considered.
Minimum of 10+ years of relevant pharmaceutical or biotechnology experience in Technical Operations, manufacturing, process development, CMC, or related functions.
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 and deep 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, cross-functional programs, and teams, including governance, performance management, contract/scope management, budgeting, executive-level escalation, influence without direct authority, and accountability for partner performance.
Strong strategic, analytical, and problem-solving skills, including 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 use budgets, forecasts, manufacturing costs, contract terms, and operational metrics to inform decisions.
Experience establishing scalable Technical Operations processes and systems; proficiency with Microsoft Office and relevant project, reporting, or data-management tools.
Demonstrated 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

Advanced degree (MS, PhD, or MBA).
Experience with drug-device combination products, nasal/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.

Responsibilities

Lead Technical Operations programs and external manufacturing activities, defining strategy, priorities, scope, timelines, deliverables, responsibilities, budgets, risks, and decision points.
Own senior-level relationships with CMOs, CDMOs, and other external partners; establish governance, performance expectations, escalation pathways, and accountability.
Provide technical leadership for formulation and process development, scale-up, technology transfer, process characterization, process validation/PPQ, continued process verification, and manufacturing lifecycle management.
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, performance, vendor changes, investigations, annual/product reviews, significant deviations, out-of-specification or atypical results, and complex manufacturing problems.
Ensure robust technical investigations, root-cause analysis, 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, coordinating evaluation of quality, regulatory, supply, financial, and business impacts.
Establish and review manufacturing, supply, and partner performance metrics and KPIs; lead lifecycle improvements, operational excellence, capacity planning, cost improvement, and risk-reduction initiatives.
Lead external partner governance and strategic 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 and communicate strategy, status, risks, financial implications, and recommendations to senior management and stakeholders.
Partner with Regulatory Affairs on CMC strategy, submissions, post-approval changes, and health authority responses; align manufacturing plans and technical decisions 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.
Govern commercial supply operations within Technical Operations, including 3PL and distribution partner performance, inventory and supply continuity, shipping/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 material planning, packaging, labeling, distribution, inventory/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.