The Position

The  Project Manager, CMC is accountable for the project and is responsible for the indirect management of CMC project teams from process development to delivery of clinical kits. 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, manufacturing, packaging, and labeling for Arrowhead drug development programs. The Associate Project Manager 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, logistics, supply chain, quality, and regulatory functions.

Responsibilities

• Act as primary point of contact for projects, facilitating communication between internal and external team members for CMC development, analytical, manufacturing, packaging, and
  labeling activities
• Communicate project status and vendor activities to Arrowhead management and stakeholders
• Manage budget, timeline, quality and deliverables for each project and vendor
• Collect and report on performance metrics for each project
• Generate and maintain project tracking tools using Smartsheet, Excel, Power Bi and other databases
• Partner with the cross functional project team (chemistry, analytical, quality, regulatory, supply chain, clinical operations) to deliver quality product on time
• 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
• Develop and maintain performance metrics for projects and external partners
•  Lead project meetings, vendor visits and conference calls
• Oversee shipments and storage of GLP, GMP, and clinical materials in accordance with Arrowhead SOPs
• Collaborate with clinical supply and supply chain to ensure materials are ready for current and up-coming developmental programs
• Manage internal and external inventory of intermediates, API, investigational product, retains, samples, and clinical supplies

Requirements

• Bachelor’s degree in a scientific field such as Chemistry, Chemical Engineering, Biochemistry, Biotechnology and 3 or more years’ experience in a pharmaceutical company, contract manufacturing organization or contract research organization or Master’s degree in a scientific field such as Chemistry, Chemical Engineering, Biochemistry, Biotechnology and 1 or more years’ experience in a pharmaceutical company, contract manufacturing organization or contract research organization.
• 0-2 years in a project management or project coordination role
• Knowledge of applicable GLP, GMP, and regulatory guidance for pharmaceutical manufacturing and testing
• Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
• Excellent verbal and written communication skills
• Ability to work with diverse professionals in a matrix environment
• Highly motivated team player willingto contribute to a growing biotech organization
• A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead

Preferred: 

• Previous experience in pharmaceutical manufacturing, 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
• Willingness and ability to travel on a limited basis (<10% of time) domestically and internationally to partner and vendor locations