Manager, Product Development & Operations

Arrowhead Pharmaceuticals, Inc.•Verona, WI

57d

About 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.

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

Nice To Haves

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

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