Scientist I, Quality Control
Arrowhead Pharmaceuticals
4 hours ago
On-site
Verona, WI
Operations
The Position:
Scientist I, Quality Control within Quality Control/Quality Organization to support analytical testing of environmental monitoring samples, pharmaceutical raw materials, in-process manufacturing samples, finished drug substance and drug product, and/or stability samples for new drug substances and drug products. Supports GLP toxicology and cGMP clinical trial material release testing and stability studies. Proficient in multiple analytical techniques; makes independent scientific decisions. Leads and mentors coworkers. Reports to QC Laboratory Management.
Responsibilities:
- Fully knowledgeable of cGMP requirements and ICH guidelines
- Works independently to meet project timelines and deliverables
- Collaborates with Analytical Development on procedural method transfers; may support method validation protocol execution
- Performs routine analytical testing of raw materials, in-process samples, finished products, and stability samples using established methods
- Executes training for assigned SOPs and participates in department training modules
- Independently completes complex instrumentation work per written test methods/procedures
- Serves as subject matter expert in instrumentation and workflow management/prioritization
- Performs analyses efficiently to support prioritized studies
- Works closely with cross-department personnel for timely/accurate deliverables
- Trains and mentors analysts
- Tracks/trends data and interprets product changes on stability
- Uses stability tracking software for data entry, review, and approval
- Leads technical discussions/brainstorming
- Troubleshoots analytical method issues (instrumentation, chemistry, test methodology, and product)
- Communicates testing challenges to QC Laboratory Management
- Maintains clear, accurate notebooks; performs technical data reviews
- Drafts COAs, investigations, deviations, and CAPAs
- Communicates effectively (written/verbal)
- Embraces cGMP/ICH requirements; works in a team environment; maintains high attention to detail
- Calibrates, maintains, and troubleshoots analytical equipment with minimal guidance
- Makes sound scientific decisions independently; serves as backup to Laboratory Management
- Demonstrates flexibility with changing priorities
Requirements:
- M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience; OR B.S. in Chemistry (or related field) with 9+ years relevant laboratory experience
- Fully knowledgeable of cGMP and ICH laboratory requirements and operations
- Proficient and demonstrated experience with analytical instrumentation, test methodology/validation/transfers, data acquisition systems, and typical cGMP policies/practices
Pay/Benefits:
- Wisconsin pay range: $90,000 USD - $108,000 USD
- Competitive salaries and an excellent benefit package
Application instructions (as stated):
- Candidates must have current, valid authorization to work in the country where this role is located.
Scientist I, Quality Control within Quality Control/Quality Organization to support analytical testing of environmental monitoring samples, pharmaceutical raw materials, in-process manufacturing samples, finished drug substance and drug product, and/or stability samples for new drug substances and drug products. Supports GLP toxicology and cGMP clinical trial material release testing and stability studies. Proficient in multiple analytical techniques; makes independent scientific decisions. Leads and mentors coworkers. Reports to QC Laboratory Management.
Responsibilities:
- Fully knowledgeable of cGMP requirements and ICH guidelines
- Works independently to meet project timelines and deliverables
- Collaborates with Analytical Development on procedural method transfers; may support method validation protocol execution
- Performs routine analytical testing of raw materials, in-process samples, finished products, and stability samples using established methods
- Executes training for assigned SOPs and participates in department training modules
- Independently completes complex instrumentation work per written test methods/procedures
- Serves as subject matter expert in instrumentation and workflow management/prioritization
- Performs analyses efficiently to support prioritized studies
- Works closely with cross-department personnel for timely/accurate deliverables
- Trains and mentors analysts
- Tracks/trends data and interprets product changes on stability
- Uses stability tracking software for data entry, review, and approval
- Leads technical discussions/brainstorming
- Troubleshoots analytical method issues (instrumentation, chemistry, test methodology, and product)
- Communicates testing challenges to QC Laboratory Management
- Maintains clear, accurate notebooks; performs technical data reviews
- Drafts COAs, investigations, deviations, and CAPAs
- Communicates effectively (written/verbal)
- Embraces cGMP/ICH requirements; works in a team environment; maintains high attention to detail
- Calibrates, maintains, and troubleshoots analytical equipment with minimal guidance
- Makes sound scientific decisions independently; serves as backup to Laboratory Management
- Demonstrates flexibility with changing priorities
Requirements:
- M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience; OR B.S. in Chemistry (or related field) with 9+ years relevant laboratory experience
- Fully knowledgeable of cGMP and ICH laboratory requirements and operations
- Proficient and demonstrated experience with analytical instrumentation, test methodology/validation/transfers, data acquisition systems, and typical cGMP policies/practices
Pay/Benefits:
- Wisconsin pay range: $90,000 USD - $108,000 USD
- Competitive salaries and an excellent benefit package
Application instructions (as stated):
- Candidates must have current, valid authorization to work in the country where this role is located.