About the Role:We're looking for a Director, Gene Therapy CMC Lead on the Manufacturing, Science & Technology team to help us expand what's possible for patients with serious diseases. Reporting to the Sr Director Manufacturing, Science & Technology you'll serve as CMC Lead providing strategic and operational leadership for the Chemistry, Manufacturing, and Controls (CMC) development of a gene therapy program from early development through clinical development, regulatory submission, and commercialization readiness.
This individual will serve as the overall CMC integrator and single point of accountability, coordinating activities across Process Development, Analytical Development, Manufacturing, Quality, Regulatory CMC, Supply Chain, and external CDMO/CRO partners.
The CMC Lead will develop and execute a comprehensive CMC strategy appropriate for the program's stage, modality, and regulatory pathway, ensuring that the manufacturing process, analytical control strategy, materials, facilities, and CMC documentation collectively support clinical development and regulatory.
What You'll Do: In this role, you'll have the opportunity to develop and execute the overall CMC strategy and integrated development plan for the gene therapy program. You'll also:
- Lead cross-functional CMC activities across Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and Supply Chain.
- Establish product and process control strategies, including CQAs, CPPs, specifications, and analytical requirements.
- Oversee process development, scale-up, technology transfer, manufacturing readiness, and process characterization.
- Provide strategic oversight of analytical development, product characterization, potency, and release testing.
- Lead CMC activities with internal teams and external CDMOs/CROs, ensuring execution against program timelines and milestones.
- Partner with Regulatory Affairs on CMC strategy, regulatory interactions, and preparation of IND/CTA and marketing application submissions.
- Identify and mitigate technical, manufacturing, supply, and regulatory risks impacting the program.
- Lead CMC decision-making, governance, and communication of program status, risks, and critical issues to senior management.
Who You Are:You have a PhD along with 5 years of experience in biopharmaceutical development, gene therapy or viral-vector programs
OR
You have a Master's along with 8 years of experience in biopharmaceutical development, gene therapy or viral-vector programs
OR
You have a Bachelor's along with 12 years of experience in biopharmaceutical development, gene therapy or viral-vector programs
You are or you also have:
- Demonstrated experience leading CMC activities across multiple development stages
- Understanding of viral-vector manufacturing and characterization
- Experience with process development, analytical development, manufacturing, and CMC regulatory requirements
- Experience working with CDMOs and external development partners
- Experience with preparation or review of CMC sections for IND/CTA and/or BLA/MAA submissions
- Demonstrated ability to lead cross-functional teams without direct authority
- Project management, communication, and strategic decision-making skills
Nice to have (but not required):- PhD, Master's or Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, Biological Sciences, Pharmaceutical Sciences, or a related discipline
- AAV experience
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.
Travel Requirements This position involves frequent [domestic/international/global] travel (up to 30%)
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Pay Range:$177,000.00-242,000.00 Annual
Life at InsmedAt 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 same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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, and meaningful opportunities to connect, volunteer, and give back
