Scientist III, Process Development at Arrowhead Pharmaceuticals in Verona, WI

Job description

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. The Position This position is part of the Process Chemistry function within Developmental Chemistry and provides technical oversight and lifecycle management for drug substance candidates manufactured by external contract manufacturing organizations (CMOs). The Scientist serves as the technical lead for externally manufactured drug substance batches and provides technical stewardship responsible for tech-transfer, monitoring, trending, and communicating critical batch data to support process improvements. The role collaborates closely with Analytical Development, Discovery, Regulatory, Quality and Manufacturing. The successful candidate will have a strong GMP background and experience with active pharmaceutical ingredient (API) manufacturing. Experience providing technical guidance of downstream process chemistry and manufacturing support for antibody-oligonucleotide conjugates (AOCs) or oligonucleotides is preferred. This position is being hired at a Scientist III level, but depending on candidates education and experience may be hired at Scientist II. Responsibilities Serves as the technical lead for one or more externally manufactured programs and provides technical stewardship throughout the product lifecycle. Performs detailed technical reviews of pre-production master batch records, executed batch records, and batch-disposition documentation. Tracks and trends key process parameters throughout the product lifecycle, including mass balance, in-process testing (IPC), critical impurities, critical quality attributes (CQAs), and batch variability. Monitors and communicates trends to Process Team members and partners with the team to define and implement improvements that enhance batch consistency, quality, and yield. Leads root-cause investigations related to manufacturing deviations, batch failures, and technical issues, and supports the implementation of appropriate corrective actions. Coordinates internal oligonucleotide manufacturing activities to ensure batch supply aligns with external vendor requirements for conjugation. Partners with the Process Development team during the technical transfer of new programs to external vendors to ensure effective transfer of process knowledge. Acts as the primary technical point of contact for externally manufactured batches, troubleshoot deviations and out-of-specification (OOS) results, and partners with Process Developmen