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 is responsible for ensuring the completion, quality, and compliance of laboratory data and reports produced within the Quality Control (QC) team. This includes the technical review of analytical testing data and related notebooks, forms, logbooks, and more 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) standards. This position will manage deadlines for review completion and aid in the organization and maintenance of data. The ideal candidate will have experience with analytical testing, either in performance or technical review.
Responsibilities:
- Evaluate QC laboratory data for compliance with analytical methods, protocols, specifications, and SOPs.
- Review sample analysis results for completeness and accurate representation of the data and report findings.
- Communicate with QC laboratory staff to proactively address the quality of laboratory documentation.
- Prepare statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction.
- Conduct SOP review and writing as well as conducts consultations for quality records.
- Work cross-functionally to harmonize data review practices and produce a consistent product.
- Perform other duties as assigned.
Requirements:
- Bachelor’s degree in Chemistry (or related scientific field).
- 2+ years’ relevant experience (pharmaceutical CMO/CRO).
- Knowledge of cGMP and cGLP 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.
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What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
