Associate Scientist II, Quality Control

Arrowhead Pharmaceuticals, Inc.; Madison (WI); Vor Ort; USD 65.000 - 95.000; Vollzeit

Benefits dieser Stelle

Benefits package

Zusammenfassung

Arrowhead Pharmaceuticals, Inc. in Madison, WI seeks an Associate Scientist II, Quality Control to support analytical testing of environmental monitoring samples, raw materials, in-process samples, finished drug substances, and stability studies.

Reports to QC Laboratory Management with responsibilities across cGMP testing and documentation. The role requires oversight of training, SOP adherence, instrument setup, and collaboration with team members to ensure timely, accurate results.

Qualifikationen

• Master's or higher in Chemistry or related field with 1+ years in GMP QC.
• Experience with cGMP laboratory requirements and operations.
• Familiar with analytical instrumentation, test methodologies, and data acquisition.

Aufgaben

• Develop understanding of cGMP requirements and apply in daily tasks.
• Meet project timelines and deliverables with guidance from leadership.
• Perform routine Environmental Monitoring sample collection in a cGMP space.

Kenntnisse

cGMP knowledge

Analytical testing

Laboratory skills

Ausbildung

Master's in Chemistry

Bachelor's in Chemistry

Tools

HPLC

GC

FT-IR

UV/Vis

KF

Jobbeschreibung

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 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.

Responsibilities

• Developing understanding and knowledge of cGMP requirements.
• With guidance from laboratory leadership, works to meet project timelines and deliverables
• Performs routine Environmental Monitoring sample collection within a cGMP Manufacturing space.
• 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
• Additional duties as assigned

Requirements

• Masters in Chemistry (or related field) with 1+ years’ relevant laboratory experience in pharmaceutical/regulated environment or Bachelors in Chemistry (or related field) with 3+ years in a GMP QC or analytical laboratory environment.
• Experience with cGMP laboratory requirements and operations
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.

Preferred

• Previous Environmental Monitoring and/or cleanroom experience.
• 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.

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.