Senior Scientist I, Quality Control (2nd Shift)

The PositionThis 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.2nd shift work hours are 1 pm – 11:30 pm, Monday - Thursday, and includes a 10% shift differential.ResponsibilitiesFully knowledgeable of cGMP requirements and ICH guidelinesWorks independently to meet project timelines and deliverables with minimal supervision to no supervisionCollaborates routinely with Analytical Development on procedural method transfers and may participate in the execution of method validation protocolsPerforms routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and proceduresProficient with various analytical instrumentation theory and practiceExecutes 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 samplesDemonstrates 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 instrumentationIs a subject matter expert in technical aspects of both instrumentation and workflow management and prioritizationPerforms analyses in a timely and efficient manner to support ongoing prioritized studiesWorks closely with other department personnel for efficient project execution and timely/accurate deliverables while building a relationship with respect and communicationTrains and mentors co-workers (analysts)Shows initiative and interest in mastering new techniques and testsAbility to track/trend data and interpret degradative changes to the product on stabilityUses stability tracking software as a repository generated results (data entry, review and approval).Owns and leads scientific technical discussions and brainstorming sessionsIdentifies and troubleshoots analytical method issues with instrumentation, general chemistry, test methodology and sample productCommunicates laboratory testing issues or challenges to laboratory managementMaintains a clear, concise, and accurate notebookPerforms technical data review on data acquired by other QC analysts as applicableDrafts technical documents such as COAs, investigations, deviations, and CAPAsPossesses excellent written and verbal communication skillsEmbraces cGMP and ICH requirements for all associated workWorks cooperatively in a team environmentDemonstrates a high attention to detailCalibration, maintenance, and troubleshooting of analytical equipment with little to no guidance from managementRoutinely makes sound, scientific decisions independently and serves as a back-up to Laboratory ManagementDemonstrates enduring flexibility and understanding with changingRequirementsM.S. in Chemistry (or related field) with 7+ years relevant laboratory experienceB.S. in Chemistry (or related field) with 9+ years of relevant laboratory experienceFully knowledgeable of cGMP and ICH laboratory requirements and operationsProficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practicesWisconsin pay range $90,000—$108,000 USDArrowhead provides competitive salaries and an excellent benefit package.All applicants must have authorization to work in the US for a company.J-18808-Ljbffr