Director, Gene Therapy Manufacturing — Lead Site Operations

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

Job summary

Precigen, Inc. in Germantown, MD, is seeking a Director of Gene Therapy Manufacturing to lead drug substance operations for clinical and commercial products. The role requires deep cGMP expertise, strategic operations leadership, and a focus on site readiness and performance standards.

The position oversees production planning, cross-functional collaboration, and continuous improvement initiatives, with responsibility for safety, quality, and efficiency across manufacturing teams.

Qualifications

• 10+ years of cGMP experience in biologics/pharma manufacturing.
• 5+ years of people leadership in Manufacturing/Quality/Engineering.
• Strong knowledge of cGMP, quality systems, regulatory readiness.
• Experience leading teams with direct and indirect reports.
• Proven ability to manage multiple priorities and site ramp-up/start-up.

Responsibilities

• Lead manufacturing operations across production, quality, materials, and support.
• Generate production schedules and ensure on-time delivery.
• Oversee on-the-floor activities and issue resolution in real-time.
• Ensure training, qualification, and documentation for safe operations.
• Partner with MS&T for scale-up, tech transfer, and continuous improvement.
• Drive Lean, 5S, Kaizen and KPI tracking.

Skills

cGMP knowledge

People leadership

Operations planning

Cross-functional leadership

Problem-solving

Financial stewardship

Education

Bachelor’s degree in Biology, Chemistry, or Chemical Engineering

Master’s degree in Chemical Engineering / Operations or related

Tools

Oracle ERP

SAP ERP

NetSuite

Lean Six Sigma

Job description

Precigen, Inc. in Germantown, MD, is seeking a Director of Gene Therapy Manufacturing to lead drug substance operations for clinical and commercial products. The role requires deep cGMP expertise, strategic operations leadership, and a focus on site readiness and performance standards.

The position oversees production planning, cross-functional collaboration, and continuous improvement initiatives, with responsibility for safety, quality, and efficiency across manufacturing teams.