Manager, Product Development & Operations

The Position

The Manager, Product Development & Operations is accountable for the project and is responsible for the indirect management of CMC project teams from process development to delivery of finished goods to depots or 3PL(s). They will manage both internal and external CMC activities. They may manage external relationships and may act as the primary contact for outsourced contract manufacturing organizations (CMO) and contract research organizations (CRO) involved with the development, analysis, distribution, manufacturing, packaging, and labeling for Arrowhead drug development programs. The Manager, Product Development & Operations will facilitate team collaboration to identify risks, challenges, and opportunities for the project. They will work with Arrowhead leadership to prioritize work and assign tasks. They will manage vendor onboarding, contracts, project budgets, timelines, KPIs and deliverables. This is a non-laboratory position with responsibilities that require cross- functional collaboration with team members from technical, legal, finance, clinical, commercial, logistics, supply chain, quality, and regulatory functions.

Responsibilities

• 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
• Generate and maintain project tracking tools using Smartsheet, Excel, Power Bi and other databases
• Work with technical, legal and finance groups to draft RFPs, track, manage and negotiate new contracts, supply agreements, confidentiality agreements, purchase orders, etc… for new and existing venders
• 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 up-coming developmental programs

Requirements

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) and a minimum of 3 years of experience in a pharmaceutical company, contract manufacturing organization (CMO), or contract research organization (CRO); or
• Master's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) and at least 1 year of relevant experience in a pharmaceutical company, CMO, or CRO.
• 0-2 years in a project management or project coordination role
• Knowledge of applicable GLP, GMP, GDP and regulatory guidance for pharmaceutical manufacturing and testing
• Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
• Excellent verbal and written communication skills
• A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead
• Ability to work prolonged periods at a desk and working on a computer.
• Aptitude for independently resolving competing priorities in a fast-paced environment
• Willingness and ability to travel on a limited basis (<25% of time) domestically and internationally to partner and vendor locations

Preferred:

• Previous experience in pharmaceutical manufacturing, operations, clinical supply, or project management roles
• Experience with Project Management Software such as Smart Sheet or MS Project
• Experience with an ERP system such as Microsoft Dynamics (D365) or SAP
• GLP or GMP Laboratory or Manufacturing experience