Senior Scientist I, Quality Control

Arrowhead Pharmaceuticals•Verona, WI

2d•$90,000 - $108,000

About The Position

This position is within the Quality Control structure, under the Quality Organization. A Senior Scientist I, Quality Control will support the analytical testing of Environmental monitoring samples, pharmaceutical raw materials, in process manufacturing samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Senior Scientist I will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Senior Scientist I is expected to be proficient in several analytical techniques and will be capable of making independent scientific decisions. The position also requires the ability to lead and mentor co-workers. This position reports to QC Laboratory Management.

Requirements

M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience
B.S. in Chemistry (or related field) with 9+ 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

Fully knowledgeable of cGMP requirements and ICH guidelines
Works independently to meet project timelines and deliverables with minimal supervision to no supervision
Collaborates routinely with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and procedures
Proficient with various analytical instrumentation theory and practice
Executes training requirements for assigned SOPs and participates in department specific training modules.
Independently completes complex instrumentation for testing according to written test methods and procedural documents to analyze samples
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 training on instrumentation as
Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
Performs analyses in a timely and efficient manner to support ongoing prioritized studies
Works closely with other department personnel for efficient project execution and timely/accurate deliverables while building a relationship with respect and communication
Trains and mentors co-workers (analysts)
Shows initiative and interest in mastering new techniques and tests
Ability to track/trend data and interpret degrative changes to the product on stability
Uses stability tracking software as a repository generated results (data entry, review and approval).
Owns and leads 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 laboratory management
Maintains a clear, concise, and accurate notebook
Performs technical data review on data acquired by other QC analysts as applicable
Drafts technical documents such as COAs, investigations, deviations, and CAPAs
Possesses excellent written and verbal communication skills
Embraces cGMP and ICH requirements for all associated work
Works cooperatively in a team environment
Demonstrates a high attention to detail
Calibration, maintenance, and troubleshooting of analytical equipment with little to no guidance from management
Routinely makes sound, scientific decisions independently and serves as a back-up to Laboratory Management
Demonstrates enduring flexibility and understanding with changing