Scientist II, Quality Control

Arrowhead Pharmaceuticals•Verona, WI

1d•$105,000 - $120,000•Onsite

About The Position

Arrowhead Pharmaceuticals is seeking a Scientist II, Quality Control to join our growing Quality organization in Verona, Wisconsin. In this role, you will provide technical leadership for analytical method validation, method transfer, and quality control testing supporting the development and commercialization of innovative RNAi therapeutics. As a Scientist II, you will lead analytical projects, serve as a technical expert for complex laboratory investigations, and collaborate closely with Analytical Development, Manufacturing, and Quality teams. You'll drive scientific decision-making, mentor junior scientists, and contribute to continuous improvement initiatives that strengthen our analytical capabilities and support product quality throughout the development lifecycle.

Requirements

Bachelor's degree in Chemistry or a related scientific discipline with 8+ years of relevant laboratory experience, or Master's degree in Chemistry or a related scientific discipline with 5+ years of relevant laboratory experience.
Fully knowledgeable of cGMP and ICH laboratory requirements and operations.
Strong attention to detail and good documentation practices; comfort working against defined hold times and turnaround targets.
Prior experience testing oligonucleotides, peptides, or other synthetic biomolecules.
Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, or LAL/endotoxin testing.
Experience supporting in-process (real-time) testing in a manufacturing-adjacent QC lab.
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.
Candidates must have current, valid authorization to work in the country where this role is located.

Responsibilities

Lead analytical method validation, method transfer, and Quality Control testing activities for raw materials, in-process samples, drug substances, drug products, and stability programs.
Independently manage analytical project timelines and deliverables while partnering with Analytical Development, Manufacturing, and cross-functional stakeholders.
Serve as the Analytical Project Coordinator for method validation, technical transfer, and analytical support activities.
Design, execute, and interpret complex analytical experiments to support process development, investigations, and product lifecycle activities.
Analyze scientific data, identify trends, investigate atypical results, and recommend appropriate follow-up actions.
Support optimization and continuous improvement of analytical methods throughout all phases of API and drug product development.
Prepare technical documentation, including: Analytical methods, Validation protocols and reports, Development reports, SOPs, Scientific presentations.
Perform technical review of analytical data generated by other QC scientists and analysts.
Support Out-of-Specification (OOS) investigations, deviations, and laboratory investigations with minimal supervision.
Lead scientific discussions and technical problem-solving sessions with internal and external stakeholders.
Mentor and provide technical guidance to junior scientists and laboratory staff.
Ensure all laboratory activities comply with cGMP requirements, ICH guidelines, and internal Quality procedures.