CMC Project Manager

The Position

The CMC Project Manager 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 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 CMC 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
• Generate and maintain project tracking tools using Smartsheet, Excel 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 external partner selection and evaluation
• 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
• 2-5 years’ experience in a pharmaceutical company, contract manufacturing organization or contract research organization.
• Knowledge of applicable GLP, GMP, GCP, GDPR, ICH, FDA, MHRA guidance for pharmaceutical manufacturing and testing
• Strong MS Excel, PowerPoint, and Word skills
• Experience managing vendor and partner relationships
• Experience with project management Software such as MS Project or Smartsheet
• Demonstrated capabilities and track record of problem solving during pre- clinical and clinical drug development in a dynamic environment
• 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:

• Previous experience in pharmaceutical manufacturing, clinical supply, or project management roles
• Experience with late-stage CMC drug development and commercialization activities
• Master’s degree in Chemistry, Chemical Engineering, Biochemistry, or related science field
• Project Management Certification
• Experience working with an ERP system such as D365
• Willingness and ability to travel on a limited basis (< 10% of time) domestically and internationally to partner locations

Compensation Description

The base salary range for this position in the selected city is $120,000 - $150,000 annually.