Team Lead – Quality Control
| Company | Arrowhead Pharmaceuticals |
|---|---|
| Location | Fitchburg, WI, USA |
| Salary | $75000 – $100000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Master’s in Chemistry (or related field) with 5+ years relevant laboratory experience
- Bachelor’s in Chemistry (or related field) with 7+ years of relevant laboratory experience
- 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
Responsibilities
- Provide leadership and guidance to a team of QC chemists, ensuring their professional growth and development.
- Set clear performance expectations, provide regular feedback, and conduct performance evaluations.
- Foster a collaborative and inclusive work environment that encourages teamwork, creativity, and innovation.
- Attend and contribute to regular leadership meetings between cross-functional departments.
- Fully knowledgeable of cGMP requirements and ICH guidelines
- Frequently works independently to meet project timelines and deliverables with minimal supervision to no supervision
- Collaborates with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
- Proficient with various analytical instrumentation theory and practice
- Executes training requirements for assigned SOPs and participates in department specific training
- Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in analyst training on instrumentation as
- Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
- Works closely with QA, Analytical Development and/or Manufacturing personnel for efficient project execution and timely/accurate deliverables
- Trains and mentors both entry chemists as well as mid-level chemists
- Ability to track/trend data and interpret degrative changes to the product on stability
- Leads and assists in scientific technical discussions and brainstorming sessions
- Identifies and troubleshoots analytical method issues with instrumentation, general chemistry, test methodology and sample product
- Communicates laboratory testing issues or challenges to senior laboratory management
- Maintains a clear, concise, and accurate notebook
- Drafts technical documents such as OOS/atypical investigations, deviations and CAPAs
- Possesses clear written and verbal communication skills
- Embraces cGMP and ICH requirements for all associated work
- Calibration, maintenance, and troubleshooting of analytical equipment in collaboration with metrology
- Routinely makes sound, scientific decisions and serves as a back-up to Senior Laboratory Management
Preferred Qualifications
- Ability to work with people at various levels of the organization
- Basic knowledge of computers and PC’s
- Ability to use windows-based software including MS Office and chromatography data collection software
- Ability to solve practical problems
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
- Ability to perform complex mathematical calculations, compute ratios, rate, and percent
- Ability to draw and interpret graphs and charts
- 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/communicate information and respond to questions from management, peers and colleagues