GxP Laboratory Systems Administrator

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to 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 involved with disease. The depth and versatility of our RNAi technologies enable us to 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, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators collaborating to bring new therapies to patients in need.

The Position

The GxP Laboratory Systems Administrator supports the development and delivery of laboratory systems, including daily administration of GxP systems across departments such as Manufacturing, CMC, QC, BioAnalytical, DMPK, and Clinical Pharmacology. Responsibilities include defining standard business processes, configuring, testing, validating software solutions, deploying across sites, and supporting these solutions. The role requires close collaboration with business units, consulting partners, and internal IS&I teams, serving as an expert resource to support company growth and influence business process improvements.

Responsibilities

Business

• Support and administer identified applications
• Investigate and resolve technical and business process issues
• Communicate issues and resolutions with users and managers
• Escalate issues to vendors as needed
• Troubleshoot and collaborate with end users and managers
• Maintain knowledge of assigned applications
• Perform other duties as assigned

Regulatory

• Perform periodic application reviews and manage user access
• Represent applications in audits
• Contribute to audit responses
• Support computer system validation and assurance projects, including change control per GxP, company policies, and SDLC
• Draft CSV/CSA documentation like validation plans, specifications, traceability matrices, test scripts, deviations, and reports

Information Systems and Informatics

• Facilitate communication between business and IS&I teams
• Escalate technical issues appropriately
• Update global systems inventory
• Coordinate application releases and updates
• Develop test scenarios and verify application installation and operation
• Document infrastructure changes (e.g., OS patches, network changes)

Requirements:

• Bachelor's degree in computer science, life sciences, or related field, or equivalent experience
• 4+ years experience managing Laboratory Information Management Systems (LIMS), Chromatography Data Systems, Spectrophotometry Systems, and supporting laboratory systems in a GxP environment
• Advanced knowledge of programs like MS Word, Excel, data acquisition systems
• Ability to multitask and manage multiple projects
• Ability to produce high-quality results under deadlines
• Effective independent and team work skills

Additional Preferred Skills

• Extensive experience validating Agilent laboratory systems (Openlab, Chemstation, Cary UV)
• Strong understanding of pharmaceutical/CRO regulations (GxP, CSV/CSA validation, 21 CFR Part 11, EU Annex 11, SDLC)
• Experience with regulated asset management and environment monitoring applications
• Knowledge of Computer System Validation, 21 CFR Part 11, Annex 11, and GxP standards
• Pharmaceutical or CRO experience
• Project Management certification

Salary Range: $90,000—$115,000 USD. Arrowhead offers competitive salaries and benefits. Applicants must be authorized to work in the US.

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