Cell Therapy Process Engineer – Tech Transfer Lead

Planet Pharma; Princeton (NJ); On-site; USD 69,000 - 83,000; Full time

Job summary

Planet Pharma in Princeton, NJ seeks an MS&T Process Engineer to provide technical leadership for technology transfer and cGMP manufacturing at a cell therapy site. You will ensure scalable, compliant processes and drive continuous improvement with speed and accuracy.

The role reports to the Manager, MS&T and requires strong expertise in cGMP, process validation, data analysis, and cross-functional project teams. Some travel will be required.

Qualifications

• BSc or advanced degree in science or chemical/biological engineering.
• Minimum 5 years of industry experience.
• Minimum 3 years in cGMP biologic/cell therapy manufacturing or process development.
• Advanced degree preferred.
• Strong knowledge of cGMP regulations and regulatory expectations.

Responsibilities

• Subject matter expert for technology transfer and new product introduction.
• Perform technology transfer facility/process/workflow/equipment gap analyses.
• Author and approve internal cGMP docs (BPRs, SOPs, sample plans).
• Lead process validation and PV strategies; support PPQs.
• Provide on-the-floor technical support, troubleshooting, and CAPA implementation.
• Analyze cGMP data and trends to drive improvements.
• Collaborate with Manufacturing, QA, and Supply Chain on equipment and material onboarding.
• Support equipment qualification documents and user requirements.
• Lead lifecycle management and regulatory alignment during tech transfers.
• Work with Process Development to test and implement new capabilities.
• Travel as needed.

Skills

cGMP

Cell therapy

Process transfer

CAPA

Data analysis

Regulatory compliance

Document control

Tech transfer

Automation

MS Office

Education

BSc in Science or Chem/Bio Eng

Advanced degree preferred

Tools

PV strategies

Data Historian

Process validation

QA/QC software

Job description

Planet Pharma in Princeton, NJ seeks an MS&T Process Engineer to provide technical leadership for technology transfer and cGMP manufacturing at a cell therapy site. You will ensure scalable, compliant processes and drive continuous improvement with speed and accuracy.

The role reports to the Manager, MS&T and requires strong expertise in cGMP, process validation, data analysis, and cross-functional project teams. Some travel will be required.