Scientist, Analytical Development, Molecule

Position: Scientist, Analytical Development, Small Molecule
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 Scientist, Analytical Development, Small Molecule on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Analytical Development, you’ll support analytical method development and contribute to the testing of small molecule candidates. While experience with inhalation products is a plus, the core responsibilities will include maintaining compliance with regulatory requirements, ensuring data integrity, and collaborating with cross-functional teams to meet project goals.

A deep understanding of GMP, quality control processes, and the pharmaceutical development lifecycle is essential for this position.

What You'll Do:
In this role, you’ll have the opportunity to take the responsibility for small molecule products analytical routine testing (inhalation combination products, tablet formulations, and oral solutions) from early-stage development through to Phase III and commercialization. You’ll also:

Ensure all testing is performed in compliance with GMP regulations and internal standard operating procedures (SOPs).Accurately recording and reporting test results, maintaining detailed and compliant documentation in accordance with GMP.Validate analytical methods using advanced techniques (e.g., HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.

Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.

Lead pre-formulation and stability studies for small molecule drug products to assess their shelf life and ensure product quality during development and commercialization.

Analyze complex data, identify potential issues in analytical methods or product quality, and propose scientifically sound solutions to overcome technical challenges.

Prepare technical documents such as protocols, development reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.

Contribute to regulatory filings (IND, NDA), including providing the necessary analytical data and documentation required for submissions to global health authorities.

Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.

Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.

Who You Are :

You have a Bachelor’s degree along with five years of experience in Chemistry. You are or you also have:

Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms.

Experience with inhalation and combination products is preferred.

Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).Ability to conduct risk assessments and develop analytical methods for the detection and control of…