Director, Drug Product – Viral Vectors
About The Position
Insmed is seeking a Director, Drug Product – Viral Vectors for its Gene Therapy Manufacturing team. Reporting to the Senior Director, Manufacturing, this role is the technical and strategic leader for development, scale-up, and lifecycle management of viral vector drug product processes. The Director will develop formulation, fill-finish, and drug product manufacturing strategies for the gene therapy portfolio, supporting programs from early-phase development through commercialization. The position leads process development, optimization, scale-up, and characterization; defines development strategies aligned with clinical timelines and regulatory requirements; oversees experimental and statistical approaches; and transfers processes to GMP manufacturing sites, including CDMOs. It also authors and reviews CMC regulatory filing sections, manages external manufacturing relationships, and supports GMP batch manufacture and investigation resolution. As a cross-functional subject matter expert, the Director works with Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical Operations, Formulation Sciences, Supply Chain, and Program Management. The role recruits and develops a team, leads working groups, and represents Drug Product in governance and leadership forums. It ensures compliance with applicable GMP, GLP, and regulatory guidance, supports audits and inspections, and promotes strong documentation and a quality-first culture. This is a hybrid role based out of Insmed’s San Diego office, with remote work available most of the time and in-person collaboration as needed. Occasional domestic travel of approximately 10%–15% is required.
Requirements
- Meet one of the following minimum education and experience requirements: Ph.D. and 5 years of experience; master's degree and 8 years of experience; or bachelor's degree and 12 years of experience in drug product development and/or manufacturing in the pharmaceutical or biotechnology industry.
- Hands-on experience with viral vector drug products, such as 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.
- Deep technical knowledge of viral vector drug product manufacturing processes and analytical methods.
- Strong understanding of ICH guidelines Q6B, Q8, Q9, Q10, and Q11, and gene therapy-specific FDA and EMA regulatory guidance.
- Excellent written and verbal communication skills, including the ability to clearly present complex technical information to senior leadership.
- Strong project management capabilities and ability to manage multiple priorities in a fast-paced environment.
- Collaborative, team-oriented approach and ability to influence without authority.
Nice To Haves
- Experience managing CDMOs and external manufacturing partners.
- Experience with statistical tools such as JMP or Minitab and process development software.
Responsibilities
- Define and own drug product development strategy aligned with clinical timelines and regulatory requirements, including IND, BLA/NDA, and MAA.
- Lead development, optimization, scale-up, and characterization of viral vector drug product processes, including formulation development and fill-finish operations.
- Oversee design of experiments and statistical approaches for process optimization and robustness studies.
- Drive technology transfer of drug product processes from development to internal and/or CDMO GMP manufacturing sites.
- Author and review CMC sections for regulatory filings, including INDs, BLAs, IND amendments, and annual reports.
- Partner with CMC Regulatory Affairs to ensure 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.
- Serve as the drug product subject matter expert on cross-functional program teams.
- Collaborate with Formulation Sciences and Analytical Development on product characterization strategies and comparability frameworks.
- Partner with Supply Chain and Program Management to ensure drug product supply continuity for clinical trials.
- Recruit, mentor, and develop a high-performing team of drug product scientists and engineers.
- Set objectives, provide performance feedback, and foster scientific rigor and innovation.
- Lead cross-functional working groups and represent Drug Product at governance and leadership forums.
- Ensure development activities comply with applicable GMP, GLP, and FDA, EMA, and ICH guidelines.
- Support internal and external audits and inspections related to drug product manufacturing.
- Promote a quality-first culture and robust documentation practices.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Mental health support and access to an Employee Assistance Program.
- Annual wellbeing reimbursement.
- Paid time off policies.
- Fertility and family-forming benefits.
- Caregiver support.
- Flexible work schedules.
- 401(k) plan with a competitive company match.
- Annual equity awards.
- Employee Stock Purchase Plan.
- Company-paid life and disability insurance.
- Learning Institute with LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities.
- Employee resource groups, service and recognition programs, and opportunities to connect, volunteer, and give back.
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What This Job Offers
Job Type
Full-time
Career Level
Director
