Plant Operations
Manufacturing Data Reviewer
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 Manufacturing Data Reviewer will provide critical support to Manufacturing and Quality Operations through the review and coordination between departments of production-related documentation and data. This role ensures that executed batch records, logbooks, and chemical usage records are accurate, complete, and compliant with cGMP requirements. The Manufacturing Data Reviewer serves as a liaison between Manufacturing (MFG) and Quality Assurance (QA) to ensure timely and effective resolution of documentation issues and supports continuous improvement of production record-keeping practices.
Responsibilities
- Review executed batch records for accuracy, completeness, and compliance with internal SOPs and cGMP regulations and coordinate corrections between departments.
- Collect, organize, and maintain batch data to support production metrics, trending, and investigations.
- Perform logbook reviews to ensure timely, accurate, and legible entries in compliance with documentation standards.
- Track and reconcile chemical usage to maintain accurate inventories, ensure compliance with material control procedures, and support production planning.
- Support preparation for audits and inspections by ensuring documentation is complete, properly filed, and readily accessible.
- Assist with continuous improvement initiatives related to documentation practices, data integrity, and cGMP compliance.
- Provide documentation support to production management, including compiling reports, maintaining databases, and supporting training documentation.
Requirements:
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
- 3 years of experience in GMP manufacturing facility.
- Familiarity with executed batch records, logbook documentation, deviation management, and chemical/material tracking.
- Experience with electronic batch record (EBR), MES, or LIMS systems is an advantage.
- Prior experience in pharmaceutical or biotech manufacturing or quality operations.
- Knowledge of cGMP documentation practices, data integrity principles, and production record-keeping requirements.
- Strong attention to detail and ability to identify errors or inconsistencies in technical records.
- Effective communicator, capable of interfacing with both Manufacturing and Quality teams to resolve documentation issues.
- Strong organizational and time-management skills; able to manage multiple priorities under tight timelines.
- Proficiency with Microsoft Office Suite
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.