Scientist - Development in Therapeutics Production & Quality

St. Jude Children's Research Hospital; Lauderdale Courts (TN); On-site; USD 86,000 - 155,000; Full time

Job summary

St. Jude Children's Research Hospital is seeking a Scientist - Development to design and execute process development experiments, including upstream and downstream operations.

The role involves small-scale cell culture, bioreactors for mammalian or bacterial culture, and purification method optimization using chromatography. Preferred candidates hold a Master's or PhD with 7+ years in GMP/biotech settings, familiarity with plasmid DNA/gene therapy vectors, and a focus on maintaining compliance

Qualifications

• Bachelor's degree in a relevant scientific field.
• 7+ years of experience in GMP/biotech environments.
• Experience in cell culture, bioreactors, and purification is preferred.

Responsibilities

• Coordinate project/process aspects within GMP/ECTL with guidance, including tech transfer and scale-up runs.
• Support revisions to SOPs and process flows.
• Assist with documentation and reporting of experimental data (batch records, HPLC reports).
• Monitor compliance with quality and regulatory requirements; address deviations.
• Assist with stock and calibration, maintenance, troubleshooting, and equipment procurement.
• Instruct staff in basic techniques and systems used in the area.
• Perform other duties to meet department goals and maintain attendance.

Skills

Cell culture techniques

GMP experience

Education

Bachelor's degree

Master's or PhD preferred

Job description

Scientist - Development

The Therapeutics Production and Quality department within our Good Manufacturing Practices (GMP) facility is looking for a Scientist - Development to design and implement process development experiments with minimal supervision including both upstream and downstream unit operations. In this role you will perform small scale cell culture experiments, set up and run bioreactors for culture of mammalian or bacterial cells, and optimize purification methods using various chromatography techniques. Experience in mammalian and bacterial cell culture, bioreactors, protein purification, plasmid DNA purification, tangential flow filtration and various other filtration techniques is preferred. You will generate purified plasmid DNA and gene therapy vectors including Lentiviral.

Job 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.

Minimum Education and/or Training

• Bachelor's degree required.

• Master's OR PhD preferred.

Minimum Experience

• Minimum Requirement: Bachelor's degree with 7+ years experience in relevant scientific area (e.g., GMP: chemistry, biology, chemical engineering, analytical chemistry, biotechnology; ECTL: cellular biology, molecular biology, immunology, biochemistry).

• Experience exception: 5+ years of experience in relevant area with Master's

• Experience exception: 3+ years of experience in relevant area with PhD

• Prior experience in relevant area to own domain (e.g., upstream/downstream cGMP experience, process development, HPLC/biological assays) strongly preferred.

• Experience in lab and scientific project coordination, maintenance, and other research support activities preferred.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $86,320 - $154,960 per year for the role of Scientist - Development in Therapeutics Production & Quality.

St. Jude is an Equal Opportunity Employer