Process Development Scientist - Therapeutics & GMP Quality

Thecentermemphis; Memphis, Northern (TN, KY); Hybrid; USD 86,000 - 155,000; Full time

Job summary

St. Jude is seeking a Scientist - Development to design and implement process development experiments for GMP cell culture and purification workflows.

The role spans upstream and downstream unit operations, including bioreactors and protein purification, with emphasis on plasmid DNA and gene therapy vectors. Responsibilities include coordinating cross-functional projects, documenting data, ensuring regulatory compliance, and supporting equipment calibration and SOP updates.

Qualifications

• Bachelor's degree required; Master’s or PhD preferred.
• 7+ years experience in GMP/biotech or related field.
• Experience in upstream/downstream processing and protein purification.
• Experience coordinating lab and project activities.

Responsibilities

• Coordinate multiple aspects of projects/processes within area (GMP/ECTL) with guidance, and execute processes (e.g., tech transfer & scale-up runs, HPLC/biologic assays, manufacturing of cellular therapeutics) utilizing appropriate techniques, equipment, and methods.
• Provide inputs regarding revisions to SOPs and/or process flows within area.
• Support development, documentation, and reporting of relevant experimental data (e.g., production batch records, HPLC reports, summary reports for manufacturing campaigns).
• Monitor and document compliance with quality and regulatory requirements; and address deviations.
• Support monitoring and stocking of supplies, and calibration, maintenance, troubleshooting, and purchase of equipment within area.
• Instruct other staff in basic techniques, procedures, and systems within area (e.g., operations of cGMP equipment and control software).
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Skills

Cell culture

Bioreactors

Purification techniques

GMP experience

Education

Bachelor's degree

Master's degree

PhD

Tools

HPLC

Tangential flow filtration

Job description

St. Jude is seeking a Scientist - Development to design and implement process development experiments for GMP cell culture and purification workflows.

The role spans upstream and downstream unit operations, including bioreactors and protein purification, with emphasis on plasmid DNA and gene therapy vectors. Responsibilities include coordinating cross-functional projects, documenting data, ensuring regulatory compliance, and supporting equipment calibration and SOP updates.