Chemistry Manufacturing & Controls
Manager, Artwork & Labeling
Office Location: Verona, WI
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 Manager, Artwork & Labeling is a detail-oriented and results-driven individual with a strong understanding of graphic design, pharmaceutical packaging regulations, GMP standards and workload management. This person is responsible for the creation, management, and implementation of commercial product labelling artwork. This position liaises and promotes exchanges in Global Operations, as well as with Regulatory Affairs, Quality, Supply Chain Planning, Marketing and Global Affiliates to ensure labelling change requests comply with company standards and are implemented in accordance with regulations and production schedules.
Responsibilities
- Align artwork process strategies with broader Supply Chain, Regulatory, Quality, and Commercial objectives.
- Establish and maintain global governance frameworks, including SOPs, KPIs, change controls, and audit readiness protocols.
- Define and implement artwork workflows, documentation controls, and system interactions with appropriate stakeholders to ensure process consistency, quality, and traceability.
- Collaborate with Packaging and Device Engineering on product label/artwork development.
- Manage mock-up and artwork requests for labeling components, from development through review and approval to production implementation.
- Collaborate with Regulatory Affairs to create mock-ups supporting regulatory submissions and licensing activities, ensuring project timelines and milestones are met.
- Prepare error-free mock-ups and artwork using graphic design software and tools, interfacing with other functions within Arrowhead as well as printing/packaging vendors.
- Arrowhead point of contact for artwork vendors.
- Coordinate with external vendors, Procurement, and Supply Chain to ensure timely production. Optimize production processes for maximum efficiency, quality, and on-time delivery.
- Research and assess global labeling regulations and guidance documents, assisting in the development of procedures, guidelines, and maintenance systems for labeling development, approval, and control, while maintaining documentation and logs both in hardcopy and electronically.
- Oversee global artwork change control processes and validation protocols.
- Other duties as assigned
Requirements
- Bachelor’s Degree in Graphic Design or a related field.
- 5 years of professional design experience.
- Proficiency in problem-solving, communication, technical writing, and organization.
- Knowledge of software programs such as Adobe InDesign, Illustrator, Acrobat, Word, Excel, PowerPoint, and Outlook.
- Strong understanding of regulatory compliance requirements (e.g., GMP, CCDS, HA submissions) and global artwork-related standards and best practices.
- Experience in pharmaceuticals, packaging, and workflow.
Preferred:
- Regulatory certifications (e.g., RAC) or equivalent professional credentials
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.