Associate Scientist II, Quality Control

Arrowhead Pharmaceuticals•Verona, WI

5d•$70,000 - $85,000

About The Position

This position is within the Quality Control structure under the Quality Organization. The Associate Scientist II supports analytical testing of environmental monitoring samples, pharmaceutical raw materials, in-process samples, finished drug substances and drug products, and stability samples for new drug substances and drug products. The role also supports testing for GLP toxicology and cGMP clinical trial material release, as well as stability studies. The Associate Scientist II performs several analytical techniques and makes sound scientific decisions with guidance from management. This position reports to QC Laboratory Management.

Requirements

Master’s degree in Chemistry or a related field and at least 1 year of relevant laboratory experience in a pharmaceutical or regulated environment, or a bachelor’s degree in Chemistry or a related field and at least 3 years in a GMP QC or analytical laboratory environment.
Experience with cGMP laboratory requirements and operations.
Familiarity with analytical instrumentation, test methodology and validations, data acquisition systems, and cGMP policies and practices.
Ability to read, analyze, and interpret SOPs, test methods, procedural guides, and technical documents; write clearly and concisely; present information effectively and respond to questions.
Ability to perform complex mathematical functions, compute ratios, rates, and percentages, and draw and interpret graphs and charts.
Ability to solve practical problems and interpret instructions in written, oral, diagram, or schedule form.
Ability to work with people at various organizational levels.
Basic computer and PC knowledge, including ability to use Windows-based software such as MS Office and chromatography data collection software.
Current, valid authorization to work in the country where the role is located.

Nice To Haves

Previous environmental monitoring and/or cleanroom experience.
Previous microbiology experience.

Responsibilities

Develop understanding and knowledge of cGMP requirements.
Work with 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.
Complete training requirements and apply relevant SOPs and associated procedural guides.
Keep training records up to date and compliant.
Develop familiarity with analytical instrumentation theory and practice, and become proficient with instruments such as HPLC, GC, FT-IR, UV/Vis, and 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 and perform analyses in a timely manner.
Work collaboratively and cooperatively with others in a team environment; show initiative and interest in learning new techniques and tests.
Identify and troubleshoot minor analytical problems involving instrumentation, general chemistry, and computer applications.
Quickly communicate analytical or sample issues to senior staff and/or management.
Maintain clear, concise, and accurate laboratory notebook or worksheet records.
Review test data acquired by others, as applicable.
Assist in drafting technical documents such as OOS/atypical investigations, deviations, and CAPAs.
Analyze data and results consistently and correctly, interpret experimental outcomes, and propose appropriate follow-up with supervision.
Embrace cGMP requirements for associated work and develop attention to detail.
Calibrate, maintain, and troubleshoot analytical equipment with supervision.
Remain flexible as priorities change and perform additional duties as assigned.