CGT Manufacturing Readiness Lead

Matica Biotechnology, Inc.; College Station (TX); On-site; USD 180,000 - 230,000; Full time

Job summary

Matica Biotechnology, Inc. in College Station, TX, seeks a senior Manufacturing Readiness Leader to oversee readiness for autologous and allogeneic CGT programs. You will coordinate with CDMO partners to ensure facilities, processes, and quality systems meet GMP expectations and regulatory requirements.

The role emphasizes leadership across Manufacturing, Quality, and Program Management, driving risk mitigation, tech transfer, and validation activities for clinical to commercial CGT programs.

Qualifications

• Bachelor’s degree and 7–10+ years of experience in cell and gene therapy, biologics, or regulated production environments.
• Experience with viral vector manufacturing and CGT tech transfer readiness is preferred.
• Prior participation in regulatory inspections or pre-approval readiness activities.

Responsibilities

• Lead end-to-end manufacturing readiness strategy and execution for assigned CGT clients.
• Define readiness criteria and success metrics for milestones like NPI, tech transfer, engineering runs, PPQ.
• Develop and own manufacturing readiness plans, timelines, and dashboards.
• Mentor junior readiness or project management staff as applicable.
• Coordinate GMP readiness activities including documentation, training, and quality systems alignment.
• Prepare readiness status and risk assessments for senior leadership.

Skills

CGT leadership

GMP compliance

Cross-functional leadership

Risk management

Strategic planning

Stakeholder management

Project governance

Education

Bachelor’s degree in life sciences

MS/PhD in related field

Job description

Matica Biotechnology, Inc. in College Station, TX, seeks a senior Manufacturing Readiness Leader to oversee readiness for autologous and allogeneic CGT programs. You will coordinate with CDMO partners to ensure facilities, processes, and quality systems meet GMP expectations and regulatory requirements.

The role emphasizes leadership across Manufacturing, Quality, and Program Management, driving risk mitigation, tech transfer, and validation activities for clinical to commercial CGT programs.