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 biotechnology industry
You are or you also have:
- Hands-on experience with viral vector drug products (AAV, lentiviral, adenoviral, or related platforms) in a GMP or development environment.
- Demonstrated experience with fill-finish processes, formulation development, lyophilization, and/or drug product characterization for biologics or gene therapy products.
- Proven track record of leading programs through IND-enabling activities and/or BLA/NDA submissions.
- Prior people management experience required.
- Deep technical knowledge of viral vector drug product manufacturing processes and analytical methods.
- Strong understanding of ICH guidelines (Q6B, Q8, Q9, Q10, Q11) and gene therapy-specific regulatory guidance (FDA, EMA).
- Excellent written and verbal communication skills; ability to present complex technical information clearly to senior leadership.
- Strong project management capabilities with the ability to manage multiple priorities in a fast-paced environment.
- Collaborative, team-oriented mindset with the ability to influence without authority.
Nice to have (but not required):- Experience managing CDMOs and external manufacturing partners preferred.
- Experience with statistical tools (JMP, Minitab) and process development software is a plus.
Where You'll WorkThis is a hybrid role based out of our San Diego office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.
Travel RequirementsThis role requires occasional domestic travel (approximately 10%-15%)
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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
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday. 
