- Location
- Verona, Wisconsin, United States · Verona, WI
- Department
- Manufacturing
- Seniority
- Senior
- Experience
- 8+ years
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
The Senior Data Reviewer serves as a technical subject matter expert responsible for oversight of complex laboratory data review activities supporting operations. This role provides advanced expertise in data integrity, audit trail review, GMP compliance, and risk-based decision-making to ensure the accuracy, reliability, and inspection readiness of internal and external laboratory data. The Senior Data Reviewer leads complex investigations, drives continuous improvement initiatives, mentors junior staff, and partners cross-functionally to strengthen compliant and efficient review practices.
2nd shift work hours are 1 pm – 11:30 pm, Monday - Thursday, and includes a 10% shift differential.
Responsibilities
- Perform advanced technical review of internal data and external CDMO datasets for compliance with specifications, GDP, and data integrity requirements
- Serve as SME for data integrity, audit trail review, and documentation standards
- Lead complex data review investigations, compliance assessments, and root cause evaluations related to deviations, discrepancies, and data integrity concerns
- Ensure all data and documentation are maintained in a state of inspection readiness
- Review and approve routine release and stability data, method validation data and report, cleaning data, IPC data, and critical manufacturing support records.
- Provide oversight of external laboratory/CDMO data quality and compliance
- Serve as a primary representative during regulatory inspections, client audits, and compliance assessments
- Assess compliance and data integrity risks, develop mitigation strategies, and drive corrective and preventive actions to reduce operational and regulatory risk
- Lead continuous improvement initiatives focused on strengthening data review effectiveness, inspection readiness, workflow efficiency, and digital enablement strategies
- Mentor and train Data Reviewers I and II; provide technical guidance and troubleshooting support
- Partner with leadership to ensure milestones, timelines, and compliance objectives are achieved
- Influence departmental procedures, review standards, and compliance strategies through technical expertise and risk-based decision-making
- Embrace statistical tools for trend analysis, system suitability trending, deviation investigations, and overall laboratory performance.
- Other duties as assigned
Requirements
- Bachelor’s degree in chemistry or (any STEM degree) and 8+ years of experience or master’s degree and 5+ years of experience in a cGMP laboratory (pharmaceutical CMO/CRO).
- Strong experience with analytical methods + data review + audit trail review
- Deep knowledge of GMP, data integrity, and regulatory expectations
- Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing.
Preferred
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Familiarity with laboratory information systems.
- Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
- Solid organizational skills with ability to adapt to changing priorities and deadlines.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
