Manager, Manufacturing Science & Technology

Manager, Manufacturing Science & Technology

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.

For patients, for each other, and for the future of science, we're in. Are you?

We're looking for a Manager, Manufacturing Science & Technology on the Manufacturing team to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Manufacturing Sciences & Technology, you'll be responsible for playing a critical role in bringing rAAV-based therapies to market by closely supporting our external manufacturing partners. You will serve as a critical technical bridge between Process Development, CMC, and GMP manufacturing, ensuring process robustness, seamless technology transfer, and sustained manufacturing excellence across development and commercial stages.

The ideal candidate will possess a good understanding of state-of-the-art AAV manufacturing knowledge, including suspension HEK
293 cell culture and ultracentrifugation-based separation processes, as well as exposure to gene therapy regulatory requirements across early and late phases.

What You'll Do:

In this role, you'll have the opportunity to lead and execute end-to-end technology transfer activities from process development through commercial-scale GMP manufacturing, including facility fit assessments and coordination of process start-up activities. You'll also be responsible for:

• Review critical documentation, including both pre- and post-execution batch records, SOPs, raw material specifications, development reports, and GMP protocols
• Serve as a person-in-plant during production campaigns, providing real-time support and ensuring alignment with established process parameters and quality standards
• Perform active process monitoring and data trending, and assist in and process improvements for the manufacture of Drug Substance and Drug Product
• Drive timely closure of process deviations in Veeva by partnering with cross-functional teams, leveraging expertise in document management systems to ensure compliance and traceability
• Support change control management for process versions and process comparability assessments
• Assist with planning and execution for process characterization and Process Performance Qualification (PPQ) activities
• Provide broad technical support across MSAT initiatives as needed, such as assistance with Statement of Work (SOW) review and submission, and contribute to supply chain risk mitigation efforts

Who You Are:

You have a Bachelor's degree along with 5 years of relevant experience in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or a related field. You are or you also have:

• Solid technical background in drug substance (upstream cell culture, downstream purification) and/or drug product operations.
• Hands-on experience interacting with GMP manufacturing, process validation, and tech transfer teams.
• Ability to work in a fast-paced and dynamic environment.
• Ability to work independently, remote from central leadership.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
• Strong verbal and written communication skills are essential.

Nice to have (but not required):

• Expertise of drug product fill process is a plus.

Where You'll Work

• This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Candidates located on the East Coast — particularly in Ohio, Massachusetts, and Rhode Island — are strongly encouraged to apply.

Travel Requirements

This position involves frequent global travel (up to 40%) for visits to our CDMO sites.

Pay Range:

$- Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the…