Manager, Manufacturing Science & Technology
About The Position
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 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 HEK293 cell culture and ultracentrifugation-based separation processes, as well as exposure to gene therapy regulatory requirements across early and late phases.
Requirements
- Bachelor’s degree along with 5 years of relevant experience in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or a related field.
- 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 Haves
- Expertise of drug product fill process is a plus.
Responsibilities
- 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.
- 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 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.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- Company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups
- Service and recognition programs
- Meaningful opportunities to connect, volunteer, and give back
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
