Group Manager, Process Development & Operations

The Position

The Group Manager Process Development & Operations is accountable for assigned project(s) and provides leadership to cross-functional CMC teams from drug substance process development through delivery of clinical kits. This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The Group Manager will have direct reports and is responsible for mentoring, performance management, and team development. In addition, this individual is partner-facing, serving as a key point of contact for stakeholders and external partners. The role will manage external relationships, including partnerships, and act as the primary contact for contract manufacturing organizations (CMOs) and contract research organizations (CROs) supporting development, analysis, manufacturing, packaging, and labeling activities for Arrowhead drug development programs.

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 vendors
• 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 and/or partner 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

• B.S. OR M.S. in a scientific field such as Chemistry, Chemical Engineering, Biochemistry, Biotechnology, or similar
• B.S. with 5+ OR M.S. with 3+ years of experience in a pharmaceutical company, contract manufacturing organization or contract research organization.
• 3+ years in a project management role
• Experience managing clients, partners, and/or vendors
• 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 willing to 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

• 6+ years 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
• 1+ years of experience as a direct people leader