Director / Senior Director, Technical Operations

The role

The Director / Senior Director, Technical Operations provides strategic leadership for external manufacturing and Technical Operations activities. This role supports the development, lifecycle management, and commercial supply of neffy.

What you will do

• Provide leadership for Technical Operations programs and external manufacturing activities
• Own senior-level Technical Operations relationships with key CMOs/CDMOs and other external partners
• Provide technical leadership for formulation and process development, scale-up, and technology transfer
• Oversee clinical and commercial manufacturing strategy and execution
• Provide senior technical review and oversight of manufacturing and process documentation
• Lead technical assessments of significant manufacturing, process, component, and supplier changes
• Establish and review manufacturing, supply, and external partner performance metrics and KPIs
• Lead external partner business and technical governance
• Represent Technical Operations on cross-functional program and leadership teams
• Partner with Regulatory Affairs on CMC strategy and regulatory submissions

Required qualifications

• Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or related scientific/technical discipline
• Minimum of 10+ years of relevant pharmaceutical/biotechnology experience in Technical Operations, manufacturing, process development, CMC, or related functions
• Significant experience managing external CMOs/CDMOs in an outsourced operating model and supporting GMP clinical and commercial manufacturing
• Knowledge of cGMP, pharmaceutical manufacturing, quality systems, formulation and process development, scale-up, technology transfer, process validation, lifecycle management, and CMC regulatory expec
• Demonstrated leadership of outsourced manufacturing relationships, complex cross-functional programs, and teams
• Strong strategic, analytical, and problem-solving capability
• Excellent written, verbal, negotiation, and presentation skills
• Strong business and financial acumen
• Experience establishing scalable Technical Operations processes and systems
• Proficiency with Microsoft Office and relevant project, reporting, or data-management tools
• Demonstrated knowledge of commercial and clinical supply operations within an outsourced model
• Ability to travel domestically and internationally up to approximately 25%

Nice to have

• 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
• Experience across multiple of these areas

Benefits

• 100% employer paid Medical, Dental & Vision for employees
• Equity
• 401k matching

About the company

ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®.