Plant Operations
Project Manager, Quality Control
Office Location: Verona, Wisconsin, United States
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Project Manager, supporting Quality Control is accountable for the planning, coordination, and successful execution of QC activities across clinical and commercial programs. This role provides indirect leadership of QC project teams and ensures high‑quality, timely, and compliant release and stability testing for internal and external programs.
They will serve as the primary liaison between Arrowhead and external partners, including contract manufacturing organizations (CMOs) and contract research organizations (CROs), overseeing analytical method transfers, method validation, release testing, stability studies, and related QC deliverables. This position drives cross‑functional alignment by facilitating collaboration across technical, quality, regulatory, supply chain, clinical, legal, and finance teams. The Project Manager identifies risks and opportunities, establishes project priorities, and ensures accurate tracking of milestones, budgets, KPIs, and vendor performance.
Responsibilities include managing vendor onboarding, contracts, proposals, and ongoing relationships; maintaining project documentation and dashboards; leading project meetings; and supporting operational readiness for QC activities. This is a non‑laboratory role requiring strong communication, organizational, and leadership skills to effectively support the operational excellence and strategic objectives of the QC organization.
Responsibilities
- Act as primary point of contact for projects, facilitating communication between internal and external team members for Quality control activities such as method transfers, method validation, in-process control sample timelines, release and stability planning/testing.
- 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 (Process development, analytical development, QA, regulatory, manufacturing, supply chain) 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 visits and conference calls.
- Oversee shipments and storage of GLP, GMP, and clinical materials in accordance with Arrowhead SOPs.
- Collaborate with clinical and/or commercial supply chain to ensure materials are ready for current and up-coming developmental and/or commercial programs.
- Manage internal and external inventory of intermediates, API, investigational product, retains, samples, and clinical and/or commercial supplies.
- Other projects as deemed appropriate.
Requirements
- Bachelor’s degree in Life Sciences with 3 years’ relevant industry experience in the pharmaceuticals or biotechnology industry required.
- 2 years in a project management or project coordination role
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia for pharmaceutical manufacturing and testing.
- Strong MS Office skills (Outlook, Excel, PowerPoint, and Word).
- 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.
- Strong verbal and written communication skills and ability to work in a cross-functional environment
- Solid organizational skills with ability to adapt to changing priorities and
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.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.