Associate Scientist II, Quality Control

Arrowhead Pharmaceuticals•Verona, WI

2d•$70,000 - $85,000

About The Position

This position is within the Quality Control structure, under the Quality Organization. An Associate Scientist II, Quality Control will support the analytical testing of Environmental monitoring samples, pharmaceutical raw materials, in-process samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Associate Scientist II will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Associate Scientist II is expected to perform several analytical techniques and can make sound scientific decisions with guidance from management. This position reports to QC Laboratory Management.

Requirements

B.S. in Chemistry (or related field) with 1-3 years of relevant laboratory experience
Experience with cGMP laboratory requirements and operations
Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.

Nice To Haves

Language Skills: Ability to read, analyze and interpret SOPs, test methods, procedural guides and associated technical documents. Ability to write in a clear and concise manner. Ability to effectively present information and respond to questions from management, peers and colleagues.
Mathematical Skills: Must be able to perform complex math functions, compute ratios, rate, and percent. Must be able to draw and interpret graphs and charts.
Reasoning Skills: Must be able to solve practical problems. Must be able to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Other Skills and Abilities: Must be able to work with people at various levels of the organization. Must have basic knowledge of computers and PC’s. Ability to use windows-based software including MS Office and chromatography data collection software.

Responsibilities

Developing understanding and knowledge of cGMP requirements.
With guidance from laboratory leadership, works to meet project timelines and deliverables
Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and/or stability samples using established test methods and procedures
Executes training requirements, applies relevant SOPs and associated procedural guides
Ensures that training records are up to date and in compliance
Familiar with various analytical instrumentation theory and practice
Trains on, and becomes proficient with, a variety of analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF, etc.)
Can set up various instrumentation for testing according to written test methods with little to no supervision
Plans and executes work related tasks with minimal supervision
Performs analyses in a timely manner
Works collaboratively with others
Shows initiative and interest in learning new techniques and tests
Identifies and troubleshoots minor analytical problems with instrumentation, general chemistry and computer applications
Quickly communicates analytical or sample issues to senior staff and/or management
Maintains a clear, concise and accurate laboratory notebook or worksheet records.
Reviews test data acquired by others, as applicable.
Aids with the drafting of technical documents such as OOS/atypical investigations, deviations and CAPAs
Possesses good written and verbal communication skills
Consistently and correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up with supervision.
Embraces cGMP requirements for all associated work
Works cooperatively in a team environment
Developing attention to detail
Calibration, maintenance, and troubleshooting of analytical equipment with supervision.
Remains flexible with changing priorities