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 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 the potential addressing of 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-based therapies to diseases outside the liver, with a clinical pipeline targeting the liver and lung, and a robust preclinical pipeline.

About the role

This position is within the Quality Control structure under the Quality Organization. The Scientist II, Quality Control, will support analytical method validation, method transfer, and testing of pharmaceutical raw materials, in-process manufacturing samples, finished drug substances and drug products, and stability sample testing activities for new drug substances and drug products. The role requires proficiency in several analytical techniques and the ability to make independent scientific decisions, as well as leadership and mentorship of co-workers. This position reports to QC Laboratory Management.

Responsibilities

• Know and adhere to Arrowhead Core Values, cGMP policies and procedures, and relevant SOPs.
• Work independently and with Analytical Development and manufacturing teams to lead project timelines and deliverables.
• Own and lead scientific technical discussions and brainstorming sessions with internal and external stakeholders.
• Guide junior scientists with technical guidance and training.
• Serve as Analytical Project Coordinator for ongoing or new Analytical Validation and technical transfer projects; take ownership of analytical requirements and provide accurate analytical results.
• Prepare Analytical Validation technical reports, presentations, SOPs, and policies and procedures.
• Support analytical methods optimization and improvement of existing methods to support all stages of API (active pharmaceutical ingredient) and drug product.
• Track and trend data, and interpret degradative changes to the product.
• Demonstrate proficiency with various analytical techniques, such as LCMS, HPLC/UHPLC, GC, FTIR, UV/Vis, and KF.
• Design and execute non-routine experiments.
• Analyze data/results, interpret outcomes, and propose appropriate follow-up actions.
• Write project documentation (e.g., Analytical test methods, developmental reports, and protocols).
• Assist with drafting Out of Specification and Deviations with minimal supervision.
• Perform testing of test samples in support of API and drug release.
• Perform technical data review on data acquired by other QC analysts as applicable.
• Other duties as assigned.

Requirements

• M.S. in Chemistry (or related field) with at least 5+ years of relevant laboratory experience, or B.S. in Chemistry (or related field) with at least 8 years of laboratory experience.
• Experience and working knowledge of various analytical techniques, such as LCMS, HPLC/UHPLC, GC, FTIR, UV/Vis, LC/MS, and KF.
• Familiarity with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.
• Skills and knowledge in handling, analyzing, and characterizing chemicals, pharmaceuticals, and related organic molecules.
• Knowledgeable of cGMP, ICH, and CDER requirements.
• Understanding of basic theories and principles of synthetic organic chemistry.
• Strong attention to detail.
• Ability to perform tasks with minimal supervision.
• Works well with others and in a team environment.
• Flexibility with changing priorities.

Pay

Wisconsin pay range: $105,000–$120,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.