Director, Drug Product – Viral Vectors

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 Director, Drug Product – Viral Vectors on the Gene Therapy Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Manufacturing, you’ll serve as the technical and strategic leader for the development, scale-up, and lifecycle management of viral vector drug product processes at Insmed. This individual will be responsible for driving the formulation, fill-finish, and drug product manufacturing strategies for Insmed's gene therapy portfolio, ensuring that programs advance seamlessly from early-phase development through commercialization. What You'll Do: In this role, you’ll have the opportunity to lead the development, optimization, and scale-up of viral vector drug product processes, including formulation development, fill-finish operations, and drug product characterization. You’ll also: Drug Product Development & Technical Leadership Define and own the drug product development strategy, ensuring alignment with clinical timelines and regulatory requirements (IND, BLA/NDA, MAA). Oversee design of experiments (DoE) and statistical approaches for process optimization and robustness studies. Drive technology transfer of drug product processes from development to GMP manufacturing sites (internal and/or CDMOs). Manufacturing & CMC Author and review CMC sections for regulatory filings (IND, BLA, IND amendments, annual reports) related to viral vector drug products. Partner with CMC Regulatory Affairs to ensure drug product development packages meet global regulatory expectations. Manage CDMO relationships for drug product activities, ensuring quality, timelines, and budget adherence. Support GMP batch manufacture, investigations, and deviation resolution. Cross-Functional Collaboration Serve as the drug product subject matter expert (SME) on cross-functional program teams, including Drug Substance, Analytical Development, Quality, Regulatory Affairs, and Clinical Operations. Collaborate with Formulation Sciences and Analytical Development to establish product characterization strategies and comparability frameworks. Partner with Supply Chain and Program Management to ensure drug product supply continuity for clinical trials. People Leadership Recruit, mentor, and develop a high-performing team of drug product scientists and engineers. Set clear objectives, provide ongoing performance feedback, and foster a culture of scientific rigor and innovation. Lead cross-functional working groups and represent Drug Product at governance and leadership forums. Quality & Compliance Ensure all drug product development activities are conducted in accordance with applicable GMP, GLP, and regulatory guidelines (FDA, EMA, ICH). Support internal and external audits and inspections for drug product manufacturing activities. Champion a quality-first culture and ensure robust documentation practices across the team. Who You Are: You meet one of the following minimum education and experience requirements: Doctor of Philosophy and 5 years of experience Master's degree and 8 years of experience Bachelor's degree and 12 years of experience in drug product development and/or manufacturing within the pharmaceutical or biotechnol…

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