Director, Drug Product – Viral Vectors (Gene Therapy)

Location: Hybrid role based out of the San Diego, California office, with remote work available most of the time and in-person collaboration as needed; occasional domestic travel of approximately 10%–15%.

Salary: $177,000–$242,000 annual.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Lead formulation development, fill-finish operations, drug product characterization, process optimization, scale-up, and lifecycle management for viral vector drug products.
• Define drug product development strategies aligned with clinical timelines and regulatory requirements, including IND, BLA/NDA, MAA, amendments, and annual reports.
• Oversee DoE and statistical approaches, process robustness studies, technology transfer, GMP batch manufacturing, investigations, and deviation resolution.
• Manage CDMO relationships and coordinate quality, timelines, budgets, supply continuity, and technology transfer to internal or external manufacturing sites.
• Serve as the drug product SME across Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical Operations, Supply Chain, and Program Management.
• Recruit, mentor, and develop drug product scientists and engineers; lead working groups and represent Drug Product in governance and leadership forums.

Requirements

• PhD with 5 years of experience, master’s degree with 8 years, or bachelor’s degree with 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, including AAV, lentiviral, adenoviral, or related platforms, in a GMP or development environment.
• Experience with fill-finish processes, formulation development, lyophilization, and/or drug product characterization for biologics or gene therapy products.
• Experience leading programs through IND-enabling activities and/or BLA/NDA submissions.
• Prior people management experience is required.
• Deep technical knowledge of viral vector drug product manufacturing processes and analytical methods.
• Strong understanding of ICH Q6B, Q8, Q9, Q10, Q11 and gene therapy-specific FDA and EMA guidance.
• Excellent written and verbal communication skills, including presenting complex technical information to senior leadership.
• Strong project management skills, ability to manage multiple priorities, and ability to influence without authority in a collaborative environment.
• Drug product development activities must comply with applicable GMP, GLP, and regulatory guidelines.

Nice to have

• Experience managing CDMOs and external manufacturing partners.
• Experience with JMP, Minitab, and process development software.

Culture & Benefits

• Purpose-driven biopharmaceutical environment focused on serious and rare diseases, curiosity, scientific progress, and meaningful patient impact.
• Hybrid work with flexible schedules and purposeful in-person collaboration.
• Medical, dental, vision, mental health, wellbeing reimbursement, and Employee Assistance Program benefits.
• Paid time off, fertility and family-forming benefits, caregiver support, life and disability insurance, 401(k) match, equity awards, and ESPP participation.
• Learning and development through LinkedIn Learning, workshops, leadership programs, mentorship, networking, employee resource groups, and service programs.

Hiring process

• Applications are accepted for 5 calendar days from the date posted or until the position is filled.
• Current hirify.global employees must apply through the Jobs Hub in Workday; unsolicited agency resumes are not accepted without a formal agreement.