Sr Manager, Regulatory Affairs CMC (Cell & Gene Therapy)

Location: Santa Monica, California, United States through 2026; relocation to Thousand Oaks, Foster City, or El Segundo, California is expected beginning in January 2027. Hybrid schedule with two remote days and three onsite days.

Salary: $143,225–$185,350 per year, plus potential annual bonus, stock-based incentives, paid time off, and benefits.

Company

Develops CAR T-cell and T-cell receptor engineered therapies and other cancer immunotherapies.

What you will do

• Lead global CMC regulatory strategies for autologous T-cell drug products and lentiviral vectors across early development, pivotal studies, registration, and post-approval stages.
• Represent Regulatory CMC on program and technical teams, translating development decisions into submission plans, health authority strategies, risk mitigations, and decision points.
• Provide regulatory guidance for T-cell manufacturing, including process changes, control strategies, specifications, potency, stability, comparability, validation, and supply continuity.
• Guide lentiviral vector manufacturing and analytical strategies covering raw materials, plasmids, cell banks, viral safety, potency, titer, purity, stability, and reference standards.
• Author and review CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, and post-approval commitments.
• Present risks, options, recommendations, and regulatory decisions to technical teams and leadership while coaching less experienced colleagues.

Requirements

• Bachelor’s degree with 8 years of experience, master’s degree with 6 years of experience, or PhD.
• Significant Regulatory Affairs CMC experience in biotechnology or biopharmaceutical development, including cell therapy and/or viral vector programs.
• Hands-on experience with autologous T-cell drug product manufacturing and lentiviral vector manufacturing is strongly preferred.
• Experience with global submissions, health authority interactions, comparability, analytical and process validation, stability, site changes, and inspection readiness.
• Strong knowledge of GMP, ICH requirements, and global CMC expectations for cell and gene therapy products.
• Ability to work in the United States and comply with the required Santa Monica onsite schedule and planned California office relocation.

Nice to have

• PharmD or PhD in a scientific discipline.
• Experience with multi-site manufacturing networks, technology transfers, external manufacturers, and testing laboratories.
• Technical expertise in individualized manufacturing controls, chain of identity and custody, cryopreservation, vector-specific analytical methods, and reference standards.

Culture & Benefits

• Patient-focused work dedicated to developing cancer treatments.
• Flexible hybrid working policy with two remote days and three onsite days.
• Medical, dental, vision, and life insurance plans.
• Paid time off and potential annual bonus and stock-based long-term incentives.
• People leadership focused on inclusion, talent development, team empowerment, and employee growth.