Engineer I, Quality Engineering

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. The company focuses on developing innovative drugs for diseases with a genetic basis, leveraging RNAi technologies to address conditions across virtually any therapeutic area, including targets not addressable by small molecules and biologics. Arrowhead’s clinical pipeline targets diseases in the liver and lung, with a promising preclinical pipeline. Headquartered in Pasadena, CA, the company 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 within the Quality Assurance department will support ongoing commercialization programs at Arrowhead. The role involves providing leadership and guidance in analytical method verification and validation to support preclinical, clinical, and commercialization activities. The position will also support the development and maintenance of quality systems for Good Manufacturing Practices (GMP).

Responsibilities

• Serve as the Quality Assurance subject matter expert on method validation, including providing guidance, review, and approval of validation strategies and documentation. Act as a data reviewer to ensure adherence to good documentation practices and data integrity.
• Draft, review, and approve procedures supporting quality systems for qualification and validation.
• Mentor Quality Assurance team members in Quality Engineering functions, such as department procedures, audits, method validation, and validation assessments.
• Collaborate with cross-functional teams to review and approve internal and vendor-generated data/documentation for validation, qualification, and commissioning activities. Provide guidance on equipment suitability for validated method execution.
• Prepare documentation and support internal and external audits.
• Support the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs related to validation activities.
• Support the development and implementation of periodic reviews for validated systems/processes, including establishing Continued Process Verification (CPV) procedures for commercial manufacturing.
• Perform other duties consistent with the position as assigned.

Requirements

• A bachelor’s degree or higher in a scientific field.
• 8+ years of experience in cGMP-regulated manufacturing, specifically in method validation-related roles within manufacturing and/or quality (with a bachelor’s degree).
• Working knowledge of GMP regulations (ICH Q2, ICH Q7, 21 CFR Part 210/211, EU Annex 11/15, and 21 CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work with minimal supervision.
• Strong interpersonal, verbal, and written communication skills.
• Proficiency in Microsoft Word and Excel.

Preferred Qualifications

• Experience with electronic document management systems in a regulated environment.

Pay

$95,000 USD - $125,000 USD (Wisconsin pay range).

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.