Senior Cryopreservation Process Engineer, GMP Cell Therapy

Scorpion Therapeutics; Raritan (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Cryopreservation Process Engineer to lead technical and operational aspects of cell processing and cryopreservation manufacturing in a GMP-regulated environment. You will drive development, scale-up, tech transfer, and continuous improvement across cross-functional teams.

The role requires a strong background in aseptic processing, cell/gene therapy manufacturing, and GMP regulations, with at least four years of cGMP experience.

Qualifications

• Bachelor's degree required in Engineering, Bioscience, or related field.
• Minimum 4 years of experience in cGMP manufacturing, process development/validation, or quality management.
• Strong understanding of aseptic processing and cell/gene therapy manufacturing with GMP regulations.

Responsibilities

• Support development, scale-up, technology transfer, facility design, startup, qualification, and operational readiness.
• Optimize processes for cell and gene therapies.
• Develop and implement GMP support procedures.
• Lead process validation, risk assessment, and change control strategies.
• Oversee equipment qualification, manufacturing IT systems, and continuous improvement initiatives.
• Act as a technical expert during inspections and troubleshooting.
• Collaborate across functions to ensure scalable, compliant, and cost-effective manufacturing.

Skills

GMP manufacturing

Cryopreservation

Aseptic processing

Cell/gene therapy manufacturing

GMP regulations

Education

Bachelor's degree in Engineering, Bioscience, or related field

Tools

CQV (Commissioning, Qualification & Validation)

Automation systems

Job description

Scorpion Therapeutics is seeking a Senior Cryopreservation Process Engineer to lead technical and operational aspects of cell processing and cryopreservation manufacturing in a GMP-regulated environment. You will drive development, scale-up, tech transfer, and continuous improvement across cross-functional teams.

The role requires a strong background in aseptic processing, cell/gene therapy manufacturing, and GMP regulations, with at least four years of cGMP experience.