Director, Gene Therapy CMC Lead
Insmed Incorporated
Summary
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.
Job description
What You'll Do
- Develop and execute the overall CMC strategy and integrated development plan for the gene therapy program.
- 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
- PhD with 5 years of experience in biopharmaceutical development, gene therapy or viral-vector programs OR
- Master's with 8 years of experience in biopharmaceutical development, gene therapy or viral-vector programs OR
- Bachelor's with 12 years of experience in biopharmaceutical development, gene therapy or viral-vector programs
- 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. This position involves frequent travel (up to 30%).
Requirements
- PhD with 5 years of experience in biopharmaceutical development, gene therapy or viral-vector programs OR Master's with 8 years OR Bachelor's with 12 years
- 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
Benefits
- Medical, Dental & Vision
- Mental Health Support
- Wellbeing Reimbursement
- Employee Assistance Program
- Paid Time Off
- Fertility & Family Benefits
- Caregiver Support
- Flexible Work Schedules
- 401(k) Matching
- Annual Equity Awards
- Employee Stock Purchase Plan
- Life & Disability Insurance
- LinkedIn Learning Access
Company overview
Insmed Incorporated is a people-first global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan, the company focuses on delivering first- and best-in-class therapies for underserved patient communities. Insmed's portfolio includes two approved therapies for chronic lung diseases: ARIKAYCE for Mycobacterium avium complex lung disease and BRINSUPRI for non-cystic fibrosis bronchiectasis. The company is advancing a diverse pipeline of mid- to late-stage investigational medicines and cutting-edge drug discovery programs spanning gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue technologies. Recognized as the No. 1 Science Top Employer for five consecutive years, Insmed employs 1,001-5,000 professionals globally and maintains a strong commitment to innovation, patient-centricity, and corporate responsibility.