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 Data Reviewer independently performs technical review of laboratory data and documentation to ensure compliance with analytical methods, specifications, GMP/GDP requirements, and data integrity standards. This role exercises independent judgment in evaluating data quality, identifying discrepancies, and resolving routine to moderately complex compliance issues. The Data Reviewer supports inspection readiness activities, contributes to continuous improvement initiatives, and serves as a technical resource to junior team members.
Responsibilities
- Perform independent technical review of internal data and external laboratory data
- Evaluate data for accuracy, completeness, and compliance with GMP and specifications
- Independently evaluate, investigate, and document discrepancies, atypical results, and documentation inconsistencies to determine impact and ensure appropriate resolution
- Review routine release and stability data, method validation data and report, IPC data, cleaning samples, and logbooks for traceability and compliance
- Communicate and collaborate with laboratory staff and CDMOs to resolve data quality issues
- Support audit readiness activities and participate in inspections
- Maintain knowledge of laboratory systems and software for effective review
- Recommend and support implementation of improvements to data review processes, documentation practices, and workflow efficiency
- Provide guidance and onboarding support to junior reviewers on review practices, documentation standards, and GMP expectations
- Embrace digital tools and opportunities for trend analysis, system suitability trending.
- Perform additional duties as assigned in support of operations
Requirements
- Bachelor’s degree in chemistry or (any STEM degree) and 5+ years GMP experience, or a Master of Science (STEM degree) with minimum 3 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO).
- Experience with analytical data review and documentation practices
- Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing.
- Working knowledge of GMP/GDP and laboratory systems
Preferred
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Familiarity with laboratory information systems, LIMS.
- 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.
Candidates must have current, valid authorization to work in the country where this role is located.
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Skills Required
- Bachelor's degree in chemistry or other STEM degree with 5+ years GMP experience, or Master of Science (STEM) with minimum 3 years cGMP laboratory experience
- Experience with analytical data review and documentation practices
- Working knowledge and experience with analytical methods: HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, Karl Fischer (KF), UV spectrometry, and microbiology testing
- Working knowledge of GMP/GDP and laboratory systems
- Support audit/inspection readiness and participate in inspections
- Evaluate, investigate, and document discrepancies and ensure appropriate resolution
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Familiarity with laboratory information systems (LIMS)
- Strong verbal and written communication skills and ability to work in a matrix environment
- Solid organizational skills and ability to adapt to changing priorities and deadlines
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.
