Bioanalytical Project Manager Jobs in Madison, WI

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 GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP systems across multiple departments including, Manufacturing, CMC, QC, BioAnalytical and DMPK, Clinical Pharmacology ad BioMarkers. The GxP Laboratory Systems Administrator will be responsible for defining standard business processes, configuring/testing/validating the software solutions, deploying the solutions across multiple Arrowhead Pharmaceuticals sites, and then supporting those software solutions. The position works closely with the business, consulting partners, and internal IS&I teams. The GxP Laboratory Systems Administrator will serve as an expert resource, bringing forth opportunities and other complementary solutions to help support the growth of Arrowhead Pharmaceuticals and influence decisions regarding business process changes.
Responsibilities
Business

• Support and system administration for identified applications
• Perform investigation and resolution efforts for technical and business process issues
• Communicate technical issues and resolutions with users and department managers
• Escalate issues to application vendors as necessary
• Troubleshoot and collaborate with end users and departmental managers
• Maintain a high level of functional subject matter knowledge for the assigned applications
• Perform other duties as assigned

Regulatory

• Perform periodic application review and management of user access
• Represent the application documentation in client and regulatory audits
• Contribute to audit finding responses
• Contribute to computer system validation and computer software assurance projects, including application change control as required by GxP, Arrowhead Pharmaceuticals policies and SDLC
• Draft CSV/CSA documentation for example, validation plans, design specifications, traceability matrices, functional user and user requirements specifications, test scripts, deviations, and summary reports

Information Systems and Informatics

• Establish open communication between the business and Information Systems and Informatics
• Triage escalation of technical issues to Information Systems and Informatics
• Perform updates to the global systems inventory for applications
• Coordinate release of new versions of applications into respective environments including Development, Testing and Production environments
• Develop business scenarios to test applications
• Verify installation and operation of applications
• Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes)

Requirements

• Bachelor's degree in computer science or life sciences, other related field, or equivalent experience
• 4+ years experience related to the administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment
• Advanced knowledge of computer programs (e.g., MS Word, MS Excel, computerized data acquisition systems)
• Ability to multi-task and participate in multiple projects and department initiatives concurrently
• Ability to produce high quality results while working under the pressure of strict deadlines
• Ability to function effectively independently, as necessary, and work with others to achieve team goals

Preferred

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

Wisconsin pay range
$90,000-$115,000 USD
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.
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