Job Information
Insmed, Inc. Senior Scientist, Analytical Development in Bridgewater, New Jersey
DUTIES:• Conduct analytical method development, validation, and project support. Identifies technical challenges during analytical method development and performs method troubleshooting. • Evaluate, design, and perform method development and validation, employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance. • Lead the analytical aspects of projects while working with other functional areas to advance projects through the development pipeline. • Design and conduct of studies in accordance with company and regulatory standards to facilitate new product development. • Ensure phase-appropriate development/qualification and readiness of analytical methods for release, characterization and stability keeping in mind the line of sight towards commercialization. • Act as an analytical subject matter expert for internal development using specific traditional and advanced analytical techniques including but not limited to GC, Dissolution, LC-MS, GCMS, XRPD, Raman, FTIR, Scanning Electron Microscopy, PSD using Malvern, SEC, DSC, and TGA; • Interact with internal partners and external partners during the technology transfers of analytical methods, clinical batch testing, stability testing and CMC compilation of assigned projects. • Identify technical challenges during analytical method development and perform method troubleshooting. • Provide accurate summaries and make recommendations to stakeholders with scientific rigor • Interpret data and solve problems by working with peers in the Analytical Development laboratory. • Perform data review, analysis, and interpretation from a variety of sources. • Prepare documents like methods, experimental plans, SOPs, development reports, validation protocols and reports.REQUIREMENTS:Must possess Master’s degree or foreign equivalent in Chemistry, Chemical Engineering, or related field plus five years of pharmaceutical industry experience as an Analytical Scientist, Scientist, or similar role. Experience, which may be gained concurrently, must include:•Five years of experience with analytical characterization of solid orals and liquid dosage forms. •Five years of experience with US, EU, and Japanese pharmaceutical regulatory requirements •Four years of experience with traditional and advanced analytical techniques, including: HPLC-UVHPLC-PDAHPLC-RIDissolutionXRPDFTIRPSD using MalvernDSCTGASpectrophotometric analysisDrug releaseChromatographic techniquesMeasuring physical parametersHOW TO APPLY:Please send cover letter and resume to lisa.zavattaro@insmed.com with subject INSM-906.