Senior Scientist, Analytical Development - Small Molecule

About the role

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?

Role In this role, you’ll have the opportunity to lead the development and optimization of analytical methods for starting materials, intermediates, drug substances, and drug products.

Responsibilities

• Utilize a wide range of analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications.
• Design and lead method validation activities to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines.
• 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.
• Collaborate with process chemistry, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.