Senior Scientist, Analytical Development - Small Molecule Drug Substances

Insmed Inc. • Bridgewater, NJ • 4h ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:We're looking for a Senior Scientist on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Manager, Analytical Development, you'll lead analytical development efforts for small-molecule drug substances and drug products. You will support early- to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline toward clinical and commercial success.What You'll Do: In this role, you'll have the opportunity to support early- to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline toward clinical and commercial success. You'll also: Develop and apply a thorough understanding of drug substance lifecycle, including reference standard materials (RSM), intermediates, and final API, and their respective quality requirements Differentiate quality and regulatory requirements across RSMs, intermediates, and APIs, to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines Understand process chemistry teams to recognize synthetic routes, impurity formation, control strategies, and critical process parameters. Collaborate with development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer Prepare, review, and approve technical documents, including standard operating procedures (SOPs), analytical methods, protocols, reports, and product specifications Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert Serve as the Analytical Lead for CMC programs, overseeing analytical deliverables, including method development, validation, and GMP testing for both internal teams and external partners Manage and oversee external service providers supporting analytical development activities, ensuring timely deliverables and continuous process improvements Lead the design and development of phase-appropriate quality control strategies, specifications, and stability programs for drug substances and drug products Contribute to CMC operations, including execution, process improvements, and development of operational capabilitiesWho You Are:You have a Master's degree along with 5 years of experience in analytical development or a Bachelor's and 7 years of experience in analytical development.You are or you also have: Strong background in pharmaceutical analytical chemistry Drug substance analytical development expertise Experience with regulatory compliance and data integrity Experience leading or contributing to cross-functional project teams, managing analytical development timelines, and communicating progress to stakeholders Deep understanding of GMP, quality control processes, and the pharmaceutical development lifecycle Strong analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications * Experience with technical t

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