Gene Therapy Manufacturing Director - Operations & Scale

Precigen, Inc; Germantown (MD); On-site; USD 170,000 - 210,000; Full time

Job summary

Precigen, Inc is seeking a Director of Gene Therapy Manufacturing, Drug Substance, based in Germantown, MD. You will provide leadership and hands-on technical expertise to drive commercial and clinical production, with accountability for site readiness, organizational design, and performance standards.

The role requires deep knowledge of upstream and downstream biological manufacturing, regulatory readiness, and strong leadership with a focus on continuous improvement and operational excellence.

Qualifications

• Bachelor’s degree in biology, chemistry, chemical engineering or related field.
• 10+ years of cGMP experience in biologics/pharma manufacturing.
• 5+ years in people leadership across manufacturing/quality/engineering.
• Experience leading teams with direct and indirect reports.
• Strong knowledge of cGMP, quality systems and regulatory readiness.
• Experience with site ramp-up, project leadership and continuous improvement.

Responsibilities

• Lead manufacturing operations across production, quality, materials and support functions.
• Generate production schedules for drug substance and ensure delivery commitments.
• Oversee on-the-floor activities and resolve manufacturing issues in real time.
• Ensure training, qualifications, and documentation for safe, compliant operations.
• Partner with MS&T and others for scale-up, tech transfer and improvements.
• Lead continuous improvement using Lean tools (5S, Kaizen, value stream mapping).
• Hire and develop manufacturing leaders, build a performance-driven culture.

Skills

Leadership

Cross-functional collaboration

Strategic planning

Problem solving

Financial stewardship

Education

Bachelor’s degree in Biology / Chemistry / Chemical Engineering

Master’s degree preferred

Tools

Oracle ERP

SAP

NetSuite

Job description

Precigen, Inc is seeking a Director of Gene Therapy Manufacturing, Drug Substance, based in Germantown, MD. You will provide leadership and hands-on technical expertise to drive commercial and clinical production, with accountability for site readiness, organizational design, and performance standards.

The role requires deep knowledge of upstream and downstream biological manufacturing, regulatory readiness, and strong leadership with a focus on continuous improvement and operational excellence.