Scientist - Development in Therapeutics Production & Quality

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

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