Engineer I, Quality Engineering (Analytical Method Validation)

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefits

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, seeks a Quality Assurance professional to lead method verification/validation activities supporting pre-clinical, clinical, and commercial programs.

The role focuses on establishing and maintaining GMP-compliant quality systems, reviewing validation documentation, and mentoring QA staff while collaborating with cross-functional teams to ensure data integrity and regulatory readiness.

Qualifications

• Bachelor’s degree or higher in a science field.
• 8+ years’ experience in cGMP manufacturing, focused on method validation.
• Working knowledge of GMP regulations (ICH Q2, ICH Q7, 21 CFR 210/211, EU Annex 11/15, and 21 CFR 11).
• Excellent attention to detail and organizational skills.
• Strong verbal and written communication abilities.
• Proficient in Word and Excel.

Responsibilities

• Serve as QA SME on method validation, review and approve validation strategy.
• Draft and approve procedures for quality systems related to qualification and validation.
• Mentor QA team in quality engineering functions.
• Collaborate with cross-functional teams to review data and vendor data for validation.
• Support deviations, change controls, and CAPAs related to validation activities.
• Support periodic reviews for validated systems/processes and CPV procedures.

Skills

Attention to detail

Organizational skills

Communication skills

Multi-tasking

Interpersonal skills

Education

Bachelor’s degree or higher in science

Tools

Microsoft Word

Microsoft Excel

Job description

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

This position within the Quality Assurance department will support ongoing programs for commercialization at Arrowhead. A key function of the position will involve providing leadership and guidance in principles of analytical method verification/validation in support of pre-clinical/clinical and commercialization activities at Arrowhead.

Generally, the position will support continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. Functions of this position will include serving as the Quality Assurance subject matter expert in method verification/validation, cross-functional interaction with internal departments to establish and/or update associated procedures/processes, review/approval of method validation documentation, performing validation assessment of changes and deviations for test methods used for GMP manufacturing.

Responsibilities

• Serve as the Quality Assurance subject matter expert on method validation. This includes providing guidance, review, and/or approval of applicable validation strategy for analytical methods and supporting validation documentation. This position will also serve as a data reviewer, ensuring adherence to good documentation practices and data integrity.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Serve as a resource to mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, method validation, validation assessments, etc.).
• Work with cross-functional teams in the review and approval of internal and vendor-generated data/documentation in support of validation, qualification, and commissioning activities. Provide guidance on suitability of applicable equipment and assessment for use for validated method execution. Prepare documentation and provide support for internal and external audits.
• Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs as related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes including establishment of CPV procedures for commercial manufacturing.
• Other duties, consistent with the position, as assigned.

Requirements

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

Preferred

• Prior experience with the use of an electronic document management system in a regulated environment is preferred.

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.