Specification Lead, Quality Operations

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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.

This position resides within the Integrated Quality Operations team and serves as the owner of the specification lifecycle for Arrowhead's product portfolio, from early phase clinical development, through late phase clinical, and commercial supply. The Specification Lead is responsible for the creation, review, approval, revision, periodic review, and version control of specifications for intermediates, drug substance, drug product, and finished goods, and for ensuring that there is agreement on and justification that the acceptance criteria are phase-appropriate, justified, tighten appropriately as programs progress, and remain aligned with filed commitments and compendial requirements.

The Specification Lead works closely with Analytical and Process Development, Quality Control, CMC, Regulatory Affairs, Manufacturing, and Supply Chain.

• Serve as the Quality owner of the specification lifecycle for intermediates, drug substance, drug product, and finished goods across clinical and commercial programs.
• Author, review, and route specifications for approval, and maintain version control, effective dating, and distribution within the electronic document management system.
• Ensure acceptance criteria are phase-appropriate and scientifically justified, working collaboratively with Analytical and Process Development, Quality Control, CMC, and Regulatory Affairs as criteria are established and tightened from early phase through process validation and commercial supply.
• Maintain alignment between approved specifications and registered or filed commitments (IND/CTA/IMPD and NDA/BLA/MAA), and ensure specification changes are assessed for regulatory impact and filing requirements prior to implementation.
• Maintain alignment with compendial requirements (USP, Ph. Eur., JP), monitor compendial forecasts and revisions, and support the assessment of the impact of monograph and general chapter changes on specifications and associated test methods.
• Lead periodic review of specifications on the defined cycle, including verification of current test methods, references, acceptance criteria, and regulatory and compendial…