The PositionThis position is within the Quality Control structure, under the Quality Organization. A 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.
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 priorities.
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
Wisconsin pay range
$90,000-$108,000 USD
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.
California Applicant Privacy Policy
