Manager, Product Development & Operations

Arrowhead Pharmaceuticals is seeking a Manager of Product Development & Operations to oversee CMC projects from process development to finished goods distribution. The role involves managing both internal and external collaboration with CMOs, CROs, and regulatory bodies. It requires experience in project management, regulatory compliance, and working with both internal and external stakeholders to ensure timely delivery of products and services.

Requirements

• Oversee global operational activities: development, manufacturing, warehousing, distribution, supply chain, logistics
• Act as primary point of contact for projects, facilitating communication between internal and external team members for CMC development, analytical, manufacturing, packaging, and labeling and distribution activities
• Partner with the cross functional project team (chemistry, analytical, quality, regulatory, supply chain, clinical operations, commercial, marketing) to deliver quality product on time
• Communicate project status and vendor activities to Arrowhead management and stakeholders
• Monitor internal and external inventory of intermediates, API, investigational product, retains, samples, and clinical supplies
• Manage budget, timeline, quality and deliverables for each project and vendor
• Develop and implement global process standards, best practices
• Develop and maintain and report KPIs for projects and external partners
• Track and review vendor invoices; collaborate with finance department to process payments
• Lead project meetings, vendor visits and conference calls
• Oversee shipments and storage of GLP, GMP, and clinical materials in accordance with Arrowhead SOPs and GDP
• Collaborate with clinical supply and supply chain to ensure materials are ready for current and upcoming developmental programs

Benefits

• Competitive salaries
• Excellent benefit package