Chromatography Data Reviewer
| Hours | Full-time, Part-time |
|---|---|
| Location | Verona, Wisconsin |
About this job
Job Description
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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Chromatography Data Reviewer will monitor the quality of laboratory data and reports and review analytical testing data and related notebooks as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
Responsibilities
- Evaluates laboratory data for compliance with analytical methods, specifications, and SOPs
- Reviews sample results for completeness and accurate representation of the data and report findings
- Communicates with laboratory staff to proactively address the quality of laboratory documentation
- Prepares statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction
- Conducts SOP review and writing. Conducts consultations for quality records
- Performs other duties as assigned
Requirements:
- Bachelor's degree or equivalent experience
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Thorough knowledge of standard pharmaceutical testing, especially analysis by chromatography, and divisional SOPs
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Strong verbal and written communication skills
- Strong attention to detail
- Ability to independently review laboratory reports as well as analytical methods and test results
- Ability to deal with multiple and changing priorities
- Ability to provide clear and concise feedback and/or documentation of results
- Ability to work in a collaborative team environment
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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