Microbiology Specialist I (Wednesday-Saturday, 2nd Shift)

KBI Biopharma, Inc.; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

KBI Biopharma, Inc. seeks an experienced microbiology leader to support programs and testing for processes, instruments, and equipment. You will develop and verify methods, perform investigations, and train staff while ensuring safety and compliance with regulations.

The role is onsite in the Durham, NC area, requiring significant lab presence and collaboration with management to maintain high quality standards in environmental monitoring, product testing, and media release activities.

Qualifications

• BS in scientific discipline with 5-7 years of technical management in microbiology or
• MS/PhD with relevant experience and 3-5 years management experience preferred.

Responsibilities

• Supports microbiological programs and testing activities for processes, instruments and equipment.
• Executes testing as required and develops/verifies methods and investigations.
• Trains staff on programs and maintains regulatory awareness.
• Performs advanced data analysis and maintains proper labeling, handling and storage of hazards.
• Ensures compliance with safety and health training and waste disposal procedures.

Skills

Microbiology

Quality microbiology

Environmental monitoring

Data analysis

Staff training

Education

Bachelor of Science in Microbiology

Master’s degree in Microbiology

Tools

Regulatory compliance

Job description

Position Summary

Responsible for supporting microbiological programs and testing activities for processes, instruments and equipment. ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels. This person is responsible for the aspects of the following programs as directed by management: Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable) Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates) Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests) Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host) Media Release Laboratory Support

Position Responsibilities

• Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals.
• May perform testing when required.
• understands monitoring programs and methods and conducts troubleshooting analysis.
• Develop and execute method verifications and qualification protocols and investigations are performed appropriately.
• May execute testing when required.
• Makes detailed observations and carries out advanced data analysis.
• Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed.
• Familiarity with current regulations and scientific literature.
• Maintains current state of training prior to execution of tasks.
• Ensures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory.
• Ensures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training, including handling hazardous waste.
• Execute and review routine Microbial Laboratory work.

Minimum Requirements

• Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 5-7 years of technical management experience; or a master’s degree with 3-5 years or a Doctorate degree in Microbiology study and 1-3 years related experience and/or equivalent training preferred.
• It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory a minimum of 40%.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.