Biochemistry Analyst II

CARsgen Therapeutics Corpora - Durham, NC

Full-time - Entry Level

Durham, NC

About the position

The Biochemistry Analyst II position is responsible for conducting microbiological assays and environmental monitoring to ensure product quality and compliance with industry standards. This role involves preparing microbial cultures, participating in validation studies, and maintaining laboratory operations, all while adhering to Good Manufacturing Practices (GMP).

Responsibilities

• Conduct microbiological assays such as growth promotion of media, finished product sterility testing, and endotoxin testing of products and raw materials.
• Perform environmental monitoring of room air and surfaces in classified areas using laser particle counters and biological air samplers.
• Monitor environmental conditions of compressed gases for viable and nonviable particles, oil, and moisture.
• Prepare and maintain microbial cultures and stock solutions.
• Participate in validation and qualification studies for microbiological methods, classified areas, and clean utilities.
• Initiate deviations and laboratory investigations as needed.
• Participate in laboratory operations including equipment maintenance and inventory management.
• Review assay results, environmental monitoring data, and logbook entries.
• Make minor revisions to SOPs and forms.
• Identify and communicate risks to upper management.

Requirements

• Bachelor of Science degree in microbiology, biochemistry, or a related life science.
• Experience in GMP quality control, quality assurance, or manufacturing preferred.
• Background in aseptic processing, environmental monitoring, pharmaceutical manufacturing, or pharmaceutical microbiology preferred.
• Understanding of applicable USP, ICH, and Ph Eur standards is preferred.
• Excellent verbal and written communication skills.
• Some experience troubleshooting analytical equipment and methods preferred.
• Ability and desire to work in a fast-paced, team-oriented environment.