Manager / Senior Manager, Technical Operations

The role

The Manager / Senior Manager, Technical Operations executes programs supporting the development and commercial supply of neffy. This role provides technical and operational leadership across the ARS outsourced manufacturing network.

What you will do

• Manage cross-functional Technical Operations projects and interactions with external partners
• Serve as a Technical Operations point of contact for assigned external manufacturing partners
• Provide technical oversight of formulation, process development, scale-up, and technology transfer
• Plan and support clinical and commercial manufacturing campaigns
• Review manufacturing and process documentation for technical accuracy
• Lead or support technical assessment and resolution of manufacturing deviations and process issues
• Assess proposed manufacturing and process changes for technical impact
• Monitor and trend manufacturing and process performance data
• Support vendor selection, onboarding, and qualification activities
• Support preparation and review of CMC information for regulatory submissions

Required qualifications

• Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or a related scientific/technical discipline
• Minimum of 5 years of relevant pharmaceutical/biotechnology experience in Technical Operations, manufacturing, process/formulation development, CMC, supply chain, or a related function
• Strong working knowledge of current Good Manufacturing Practices (cGMP), pharmaceutical manufacturing operations, and applicable quality systems and regulatory expectations
• Demonstrated technical understanding of formulation, manufacturing processes, scale-up, technology transfer, process validation, and process performance
• Strong project and vendor management skills
• Strong analytical and problem-solving skills
• Excellent written, verbal, and presentation skills
• Proficiency with Microsoft Office and project/reporting tools
• Working knowledge of commercial and clinical supply operations relevant to Technical Operations

Nice to have

• experience with project management, continuous improvement, or operational excellence methodologies
• direct experience in commercial and clinical supply operations, 3PL interfaces, serialization/EPCIS and DSCSA requirements, and/or clinical IRT/IWRS processes
• An advanced degree
• 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

Benefits

• Equity
• 401k matching
• 100% employer paid Medical
• 100% employer paid Dental
• 100% employer paid Vision

About the company

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