Sr. Project Manager CMC

The Position

This position is responsible for the management of outsourced contract manufacturing organizations (CMO) and contract research organizations (CRO) involved with the development, manufacturing and analysis of API and drug products in support of Arrowhead drug development programs. This individual will implement management functions such as vendor onboarding, contract management, tracking project budgets, timelines, and deliverables. These responsibilities require cross-functional collaboration with team members from other technical, legal, finance, quality, and regulatory functions. This is a non-laboratory position that will also require the individual to collaborate and coordinate with Arrowhead CMC, process, analytical and quality/regulatory scientists to solve technical issues at partner sites.

Responsibilities

• Act as primary point of contact with outsourced manufacturing and analytical partners
• Communicate status of projects and activities at CMOs/CROs to Arrowhead management and stakeholders
• Manage timelines for deliverables and ensure product quality
• Generate and maintain project tracking tools such as Gantt charts, Excel and other databases
• Interface with internal scientists (chemistry, engineering, analytical, quality) on partner development and manufacturing activities
• Draft RFPs for new projects; track manage and negotiate new proposals
• Work with legal and finance groups on contracts for new and existing vendors: supply agreements, confidentiality agreements, purchase orders, etc…
• Track vendor invoices and collaborate with finance department to process payments
• Develop and maintain performance metrics for external partners
• Assist in partner selection strategy and evaluation
• Lead project meetings and conference calls
• Facilitate internal discussions to obtain team consensus and decisions
• Oversee shipments and storage of GLP/GMP materials in accordance with Arrowhead SOPs
• Manage supply chain to ensure adequate clinical supplies for current and up-coming developmental programs
• Manage internal and external inventory of product retains, product samples, clinical supplies and outsourced product samples
• Manage CMC outsourcing budget
• Could manage a team of Project Managers, Coordinators and ensure their area of responsibility delivers upon Arrowhead goals and objectives

Requirements:

• Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, Biotechnology or other scientific field
• Five years' experience in a pharmaceutical company, contract manufacturing organization or contract research organization with minimum of two years in a project management role.
• Domestic and international shipping oversight/experience
• Knowledge of cGMP and cGLP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents
• Strong MS Excel, Project, PowerPoint, and Word skills
• 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 and ability to work with diverse professionals in a matrix environment
• Excellent organizational skills
• Highly motivated team player willing to contribute to a growing biotech organization
• A detail oriented self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead

Preferred:

• Master's degree in Chemistry, Chemical Engineering, Biochemistry or related science field
• Project Management Certification
• Experience with late-stage CMC drug development and commercialization activities
• ERP system experience