p>Scientific/Laboratory • 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 needed • 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. Masters in Chemistry (or related field) with 5+ years relevant laboratory experience Bachelors 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.