Associate Scientist II, 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 (RNAi) mechanism to induce rapid, deep, and durable knockdown of target genes. RNAi is a natural cellular process that inhibits gene expression, affecting protein production. Arrowhead’s RNAi-based therapeutics leverage this pathway to address diseases with a genetic basis, often characterized by protein overproduction. The versatility of our RNAi technologies enables us to target conditions across therapeutic areas and pursue disease targets not addressable by small molecules or biologics. Arrowhead leads the field in expanding RNAi applications beyond the liver, with a clinical pipeline targeting liver and lung diseases and a robust preclinical pipeline. Headquartered in Pasadena, CA, Arrowhead has research and development teams in Madison, WI, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI.

About the role

This position is within the Quality Control structure, under the Quality Organization. The Associate Scientist II, Quality Control, will support analytical testing of pharmaceutical raw materials, in-process samples, finished drug substances and drug products, and stability sample testing for new drug substances and products. The role also includes Environmental Monitoring sample collection, testing for GLP Toxicology and cGMP Clinical Trial material release, and stability studies. The Associate Scientist II will perform multiple analytical techniques and make sound scientific decisions with guidance from management. This position reports to the QC-EM Scientist.

Responsibilities

• Develop understanding and knowledge of cGMP requirements.
• Work with guidance from laboratory leadership to meet project timelines and deliverables.
• Perform routine Environmental Monitoring sample collection within a cGMP Manufacturing space.
• Perform routine analytical testing of pharmaceutical raw materials, in-process samples, finished products, and/or stability samples using established test methods and procedures.
• Execute training requirements, apply relevant SOPs, and follow associated procedural guides.
• Ensure training records are up to date and in compliance.
• Familiarize with various analytical instrumentation theory and practice.
• Train on and become proficient with analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF).
• Set up instrumentation for testing according to written test methods with little to no supervision.
• Plan and execute work-related tasks with minimal supervision.
• Perform analyses in a timely manner and work collaboratively with others.
• Show initiative and interest in learning new techniques and tests.
• Identify and troubleshoot minor analytical problems with instrumentation, general chemistry, and computer applications.
• Communicate analytical or sample issues to senior staff and/or management promptly.
• Maintain clear, concise, and accurate laboratory notebook or worksheet records.
• Review test data acquired by others, as applicable.
• Assist with drafting technical documents such as OOS/atypical investigations, deviations, and CAPAs.
• Possess good written and verbal communication skills.
• Consistently and correctly analyze data/results, interpret outcomes, and propose follow-up with supervision.
• Embrace cGMP requirements for all associated work and work cooperatively in a team environment.
• Develop attention to detail.
• Perform calibration, maintenance, and troubleshooting of analytical equipment with supervision.
• Remain flexible with changing priorities.
• Perform additional duties as assigned.

Requirements

• B.S. in Microbiology, Chemistry, or a related field, with 1–3 years of relevant laboratory experience.
• Experience with cGMP laboratory requirements and operations.
• Familiarity with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.

Preferred Qualifications

• Previous Environmental Monitoring and/or cleanroom experience.
• Previous Microbiology experience.

Skills

• Language Skills: Ability to read, analyze, and interpret SOPs, test methods, procedural guides, and associated technical documents. Ability to write clearly and concisely. Ability to effectively present information and respond to questions from management, peers, and colleagues.
• Mathematical Skills: Ability to perform complex math functions, compute ratios, rates, and percentages, and draw and interpret graphs and charts.
• Reasoning Skills: Ability to solve practical problems and interpret instructions furnished in written, oral, diagram, or schedule form.
• Other Skills and Abilities: Ability to work with people at various organizational levels. Basic knowledge of computers and PCs, including Windows-based software (MS Office) and chromatography data collection software.

Pay

Wisconsin pay range: $70,000–$85,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.