Scientist I, Quality Control

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical 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, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved in disease. Arrowhead’s RNAi technologies enable addressing conditions across virtually any therapeutic area, including disease targets not otherwise addressable by small molecules and biologics. The company leads the field in bringing RNAi therapies outside of the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline.

About the role

This position is within the Quality Control structure under the Quality Organization. The Scientist I, Quality Control will support analytical testing of environmental monitoring samples, pharmaceutical raw materials, in-process manufacturing samples, finished drug substances and drug products, and stability sample testing for new drug substances and products. The role also supports testing for GLP toxicology and cGMP clinical trial material release, as well as stability studies. The Scientist I is expected to be proficient in several analytical techniques, make independent scientific decisions, and lead and mentor co-workers.

Responsibilities

• Fully knowledgeable of cGMP requirements and ICH guidelines
• Works independently to meet project timelines and deliverables with minimal to no supervision
• Collaborates routinely with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
• Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples using established test methods and procedures
• Proficient with various analytical instrumentation theory and practice
• Executes training requirements for assigned SOPs and participates in department-specific training modules
• Independently completes complex instrumentation for testing according to written test methods and procedural documents to analyze samples
• Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and assists in training on instrumentation
• Serves as a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
• Performs analyses in a timely and efficient manner to support ongoing prioritized studies
• Works closely with other department personnel for efficient project execution and timely/accurate deliverables while building respectful and communicative relationships
• Trains and mentors co-workers (analysts)
• Shows initiative and interest in mastering new techniques and tests
• Tracks/trends data and interprets degradative changes to the product on stability
• Uses stability tracking software as a repository for generated results (data entry, review, and approval)
• Owns and leads scientific technical discussions and brainstorming sessions
• Identifies and troubleshoots analytical method issues with instrumentation, general chemistry, test methodology, and sample product
• Communicates laboratory testing issues or challenges to laboratory management
• Maintains a clear, concise, and accurate notebook
• Performs technical data review on data acquired by other QC analysts as applicable
• Drafts technical documents such as COAs, investigations, deviations, and CAPAs
• Possesses excellent written and verbal communication skills
• Embraces cGMP and ICH requirements for all associated work
• Works cooperatively in a team environment
• Demonstrates a high attention to detail
• Performs calibration, maintenance, and troubleshooting of analytical equipment with little to no guidance from management
• Routinely makes sound, scientific decisions independently and serves as a back-up to Laboratory Management
• Demonstrates enduring flexibility and understanding with changing priorities

Requirements

• M.S. in Chemistry (or related field) with 7+ years of relevant laboratory experience
• B.S. in Chemistry (or related field) with 9+ years of relevant laboratory experience
• Fully knowledgeable of cGMP and ICH laboratory requirements and operations
• Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices

Pay

Wisconsin pay range: $90,000–$108,000 USD

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.