Senior Analyst, Quality Control Microbiology

POSITION SUMMARY

Umoja Biopharma is looking for a Senior Analyst, Quality Control Microbiology to perform testing and monitoring activities in support of the QC Microbiology laboratory and manufacturing areas at Umoja’s lentiviral vector manufacturing facility.

This role reports to the Senior Manager, Quality Control Microbiology and will be based fully onsite in Louisville, CO.

REQUIREMENTS 

Specific responsibilities include:  

• Performs and reviews routine Quality Control laboratory work, including environmental monitoring, clean utility sampling and testing, microbiological material qualification and maintenance, microbial identification, raw material sampling and inspection, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing
• Generates and revises Quality Control documents according to established document management processes
• Assists in the development of training materials and independently delivers training to staff for QC programs, systems, and processes
• With management oversight, executes qualification/validation activities for QC laboratory equipment, instruments, and systems
• With management oversight, executes internal and external method establishment (e.g., qualify, validate, verify, transfer) protocols to ensure QC readiness for production activities
• Initiates and supports microbial excursion investigations related to facility and personnel monitoring programs (e.g., environmental monitoring, aseptic gowning, utility monitoring, etc.) through collaboration with other functions (Engineering, Manufacturing, MSAT, etc.)
• Applies and advances Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems
• Prepares, ships, and tracks samples to outside testing laboratories
• Demonstrates the Umoja values as part of a high-performing, people-focused, inclusive, and collaborative organization
• Performs additional duties within the Quality organization, as required

The successful candidate will have:

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with 3-5 years of experience working in a cGMP regulated QC environment. Equivalent combinations of education and experience will be considered.
• A passion for teamwork and unwavering commitment to purpose, team success, and contribution to an outstanding workplace culture
• An understanding of Operational Excellence/Continuous Improvement philosophies and experience with practical application in a regulated laboratory environment

Preferred Qualifications:  

• Quality Control experience in an FDA-regulated industry supporting cGMP manufacturing areas
• Previous experience working in a clean room environment
• Previous experience working in cGMP cell and gene therapy manufacturing and/or testing facility
• Previous experience implementing a Laboratory Information Management System along with associated processes and documents

Physical Requirements:  

• Ability to work on-site 5 days/week at Umoja’s manufacturing facility in Louisville, CO
• Ability to aseptically gown and work while standing for extended periods of time
• Ability to regularly lift 20 lbs. and periodically lift up to 50 lbs.

 Senior Analyst, Quality Control Microbiology Salary Range: $71,000 - $87,800

Specialist, Quality Control Microbiology Salary Range: $92,900- $97,545