Project Manager, CMC

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient delivery methods, Arrowhead therapies trigger RNA interference to induce rapid, deep, and durable gene knockdown. RNA interference, or RNAi, is a natural mechanism in cells that inhibits specific gene expression, affecting protein production. Arrowhead's RNAi-based therapeutics leverage this pathway to address various diseases. Focused on genetic diseases characterized by overproduction of certain proteins, Arrowhead's versatile RNAi technologies aim to target conditions across therapeutic areas, including those not addressable by small molecules or biologics. The company is pioneering efforts to bring RNAi therapies beyond liver diseases, with targets in liver and lung, and a pipeline of preclinical candidates. Headquartered in Pasadena, CA, with R&D teams in Madison, WI, and San Diego, CA, Arrowhead's employees are innovative, collaborative scientists committed to developing new therapies for patients in need. The Position The Project Manager, CMC, is responsible for managing CMC project teams from process development through to clinical kit delivery. This includes managing internal and external CMC activities, vendor relationships, and acting as the primary contact for CMOs and CROs involved in development, analysis, manufacturing, packaging, and labeling. The role involves facilitating team collaboration, identifying risks, and working with leadership to prioritize tasks. Responsibilities include managing vendor onboarding, contracts, budgets, timelines, KPIs, and deliverables. This non-laboratory role requires cross-functional collaboration with teams across technical, legal, finance, clinical, logistics, supply chain, quality, and regulatory functions. Responsibilities Act as the primary contact for projects, facilitating communication among internal and external teams involved in CMC activities. Communicate project status and vendor activities to management and stakeholders. Manage project budgets, timelines, quality, and deliverables. Collect and report performance metrics for projects. Maintain project tracking tools using Smartsheet, Excel, Power BI, and other databases. Partner with cross-functional teams to ensure quality and timely delivery of products. Draft RFPs, manage contracts, and negotiate agreements with vendors. Review vendor invoices and collaborate on payments. Develop and monitor performance metrics for projects and partners. Lead project meetings, vendor visits, and conference calls. Oversee shipments and storage of clinical materials according to SOPs. Coordinate with clinical supply and supply chain teams to prepare materials. Manage inventory of intermediates, API, investigational products, and samples. Requirements Bachelor's or Master's degree in a scientific field (e.g., Chemistry, Chemical Engineering, Biochemistry, Biotechnology) with relevant experience. 0-2 years in project management or coordination roles. Knowledge of GLP, GMP, and regulatory guidelines. Proficiency in MS Office applications. Excellent communication skills. Ability to collaborate in a matrix environment. Motivated team player with attention to detail and organizational skills. Additional preferred experience includes pharmaceutical manufacturing, clinical supply, project management software (e.g., Smartsheet, MS Project), ERP systems (Microsoft Dynamics, SAP), and GMP laboratory or manufacturing experience. Willingness to travel domestically and internationally ( Salary range in Wisconsin: $70,000—$100,000 USD. Arrowhead offers competitive salaries and benefits. Applicants must have authorization to work in the US. California Applicant Privacy Policy J-18808-Ljbffr

Location: verona, IT

Posted Date: 6/16/2025