Director, Gene Therapy CMC Lead

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with frequent travel of up to 30%.

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 the CMC strategy and integrated development plan for a gene therapy program from early development through clinical development, regulatory submission, and commercialization readiness.
• Coordinate cross-functional activities across process development, analytical development, manufacturing, quality, regulatory CMC, supply chain, and external CDMO/CRO partners.
• Establish product and process control strategies, including CQAs, CPPs, specifications, and analytical requirements.
• Oversee process development, scale-up, technology transfer, manufacturing readiness, process characterization, product characterization, potency, and release testing.
• Partner with Regulatory Affairs on regulatory interactions and IND/CTA and marketing application submissions.
• Lead CMC governance and decision-making while identifying and mitigating technical, manufacturing, supply, and regulatory risks.

Requirements

• PhD and 5 years, Master’s and 8 years, or Bachelor’s and 12 years of experience in biopharmaceutical development, gene therapy, or viral-vector programs.
• Experience leading CMC activities across multiple development stages.
• Understanding of viral-vector manufacturing and characterization.
• Experience with process development, analytical development, manufacturing, CMC regulatory requirements, and external CDMO or development partners.
• Experience preparing or reviewing CMC sections for IND/CTA and/or BLA/MAA submissions.
• Ability to lead cross-functional teams without direct authority, with strong project management, communication, and strategic decision-making skills.

Nice to have

• Degree in biochemistry, biotechnology, chemical engineering, biological sciences, pharmaceutical sciences, or a related discipline.
• AAV experience.

Culture & Benefits

• Fully remote work with connection to the hirify.global team and community.
• Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service programs, and volunteer opportunities.