Senior, Cryopreservation Process Engineer CAR-T

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

Role

Senior Cryopreservation Process Engineer leading technical and operational aspects of cell processing and cryopreservation manufacturing within a GMP-regulated environment.

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.

Requirements

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

Preferred

experience in cell/gene therapy (CAR-T), equipment CQV, technology deployment, and continuous improvement methodologies like Lean or Six Sigma.

HighValue

expertise in cell/gene therapy manufacturing, cryopreservation, GMP operations, validation, and automation systems.

WorkSetup

based in Raritan, NJ, with an emphasis on cross-functional collaboration and operational excellence.