Chemistry Manufacturing & Controls
Data Reviewer, Analytical Development
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 Data Reviewer will ensure the quality of laboratory data and reports produced within Analytical Development (AD). This includes the review of 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 from AD for compliance with analytical methods, specifications, and SOPs.
- Reviews sample analysis results from AD for completeness and accurate representation of the data and report findings
- Communicates with AD 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 laboratory staff and/or project leader for correction.
- Conducts SOP preparation and review as well as consultation for GMP and Quality records.
- Performs other duties as assigned.
Requirements:
- Bachelor’s degree in Chemistry (or related scientific field).
- 3+ years’ relevant experience (pharmaceutical CMO/CRO).
- Knowledge of cGMP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents.
- 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.
All applicants must have authorization to work in the US for a company.