We are seeking a Quality Control (QC) Microbiology Specialist to join the Quality Control team at Kriya Therapeutics. This induvial will play a critical role in the qualification of Kriya’s Manufacturing Facility, and working closely with Engineering and Manufacturing, will be responsible for developing Aseptic Qualification, EM Program, Method Validation, and other programs required for start-up. In addition, the individual will also provide technical knowledge and support routine testing including Environmental Monitoring, bioburden, and endotoxin.
• Provides support for coordinating execution of activities and/or projects
• Perform cGMP Microbial testing (Environmental Monitoring, Gas Monitoring, Bioburden and Endotoxin testing)
• Execute phase-appropriate test method validation protocols
• Author, review and revise SOP and protocols for microbiological assays
• Participate in GMP validation activities for laboratory equipment, including the development and execution of IQ/OQ/PQ Testing
• Implement and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, cGMP documentation, and method training)
• Support the implementation of Aseptic Process Simulation and operator aseptic qualification programs
• Lead and support deviations, investigation, CAPAs and continuous improvement initiatives
• Minimum BS in Microbiology or other related field
• 4+ years of experience in a cGMP/GxP environment is performed
• Hands on experience with environmental monitoring and gas monitoring
• Hands on experience with bioburden, endotoxin, and other Microbiological methods is preferred
• Excellent verbal and written communication skills, detailed-oriented personality
• Experience training and/or mentoring laboratory analysts
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.
To apply for this job please visit workforcenow.adp.com.