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 an Associate Director, 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 be responsible for leading and overseeing analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including but not limited to oral solid, oral liquid, inhalation, and other specialized formulations. This role will provide strategic and technical leadership for analytical method development, qualification, validation, troubleshooting, and transfer activities to support product development from early-stage research through commercialization.
What You'll Do:
In this role, you’ll have the opportunity to lead analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including oral solid, oral liquid, inhalation, and other emerging technologies. You’ll also:
Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization.
Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations.
Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing.
Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages.
Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support.
Serve as the analytical subject matter expert for characterization of drug substances, intermediates, excipients, and drug products, including impurity profiling, degradation pathways, extractables and leachables assessments, and stability-indicating methodologies.
Support formulation and process development activities through analytical troubleshooting, root cause investigations, and data-driven recommendations.
Lead analytical method transfer activities between development, manufacturing, and external testing laboratories to ensure successful execution and regulatory compliance.
Establish scientifically justified specifications and acceptance criteria for raw materials, drug substances, intermediates, and finished products throughout the product lifecycle.
Author, review, and provide analytical content for regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and other global filings. Support responses to regulatory agency questions and inspections.
Collaborate closely with Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing, and Project Management teams to achieve program objectives and development timelines.
Ensure analytical activities are conducted in compliance with cGxP, ICH guidelines, USP/EP/JP requirements, and applicable regulatory standards.
Evaluate emerging analytical technologies and…