Scientist - Development in Therapeutics Production & Quality

Socket.dev; Memphis (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 for both upstream and downstream operations within a GMP setting.

You will perform small-scale cell culture, operate bioreactors for mammalian or bacterial culture, and optimize purification methods using chromatography techniques. The role requires Bachelor's degree with 7+ years of relevant experience; Master's or PhD is preferred.

Qualifications

• Bachelor's degree in a relevant science required.
• Master's or PhD preferred.
• 7+ years experience in GMP/related field.
• Experience with cell culture, bioreactors, and purification techniques.
• Ability to coordinate projects and document results.

Responsibilities

• Coordinate project processes in GMP/ECTL with guidance, including tech transfer & scale-up runs, HPLC/biologic assays, manufacturing of cellular therapeutics.
• 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, 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

Protein purification

Chromatography

GMP knowledge

Education

Bachelor's degree

MS or PhD preferred

Tools

HPLC

Filtration systems

Chromatography equipment

Job description

Join our Team!

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.

Explore our exceptional benefits!

St. Jude is an Equal Opportunity Employer

No Search Firms

St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.