Director, Drug Product – Viral Vectors

Insmed • San Diego, CA

4d • Hybrid

About The Position

Insmed is seeking a Director, Drug Product – Viral Vectors to join 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 lead formulation, fill-finish, and drug product manufacturing strategies for the gene therapy portfolio, supporting programs from early-phase development through commercialization.

The role leads drug product development and optimization, technology transfer to GMP manufacturing sites, regulatory CMC contributions, and CDMO relationships. It serves as the drug product subject matter expert across program teams and partners with groups including Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical Operations, Supply Chain, and Program Management.

The Director recruits, mentors, and develops a team of drug product scientists and engineers, while fostering scientific rigor, innovation, quality, and robust documentation. The position is hybrid and based in 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 education and experience combinations: 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 within the pharmaceutical or biotechnology industry.
• Hands-on experience with viral vector drug products, such as AAV, lentiviral, or adenoviral vectors, 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 mindset 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 in alignment with clinical timelines and regulatory requirements.
• Lead development, optimization, and scale-up of viral vector drug product processes, including formulation development, fill-finish operations, and product characterization.
• Oversee design of experiments and statistical approaches for process optimization and robustness studies.
• Drive technology transfer of drug product processes from development to internal GMP manufacturing sites and/or CDMOs.
• Author and review CMC sections for regulatory filings, including INDs, BLAs, IND amendments, and annual reports.
• Partner with CMC Regulatory Affairs to ensure drug product development packages meet global regulatory expectations.
• Manage CDMO relationships for drug product activities, including quality, timelines, and budget adherence.
• Support GMP batch manufacture, investigations, and deviation resolution.
• Serve as drug product subject matter expert on cross-functional program teams.
• 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.
• Recruit, mentor, and develop a high-performing team of drug product scientists and engineers; set objectives and provide ongoing performance feedback.
• Lead cross-functional working groups and represent Drug Product at governance and leadership forums.
• Ensure drug product development activities comply with applicable GMP, GLP, and FDA, EMA, and ICH guidelines.
• Support internal and external audits and inspections for drug product manufacturing activities.
• Champion a quality-first culture and robust documentation practices.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Mental health support, annual wellbeing reimbursement, and access to an Employee Assistance Program.
• Generous paid time off policies.
• Fertility and family-forming benefits and caregiver support.
• Flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match.
• Annual equity awards and participation in an Employee Stock Purchase Plan.
• Company-paid life and disability insurance.
• Company Learning Institute resources, including 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director