Microbiology Supervisor (Wednesday-Sunday, Second Shift)

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, is seeking an experienced quality microbiology leader to oversee testing and support for contract manufacturing operations. You will manage laboratory programs, train staff, ensure GMP compliance, and drive documentation and reporting.

Candidates should hold a B.S. in microbiology with 4–5 years of technical management (or advanced degree) and show strong collaboration, integrity, and customer service focus while staying current with regulations and scientific

Qualifications

• Bachelor of Science degree in a scientific discipline with a minimum of 4–5 years of technical management experience, or a Master’s degree with 3 years of experience, or a Doctorate in Microbiology with 1 year related experience and/or equivalent training.
• 0+ years of managerial experience.
• Knowledge of GMPs and biotechnology-derived product regulations.
• Ability to react to change productively and handle other essential tasks as assigned.
• Track record in: Strong orientation for Quality and Customer Service; Demonstrated respect for individuals; Demonstrated contribution to science; High integrity and personal responsibility; Strong collaboration and team building.

Responsibilities

• Plan and execute routine microbial laboratory work using technical discretion for program goals.
• Utilize technical expertise to execute and interpret experiments, including testing when required.
• Manage employee development and conduct detailed observations and intermediate data analysis.
• Serve as a qualified trainer for the Quality Microbiology team and provide training on programmes.
• Ensure proper labeling, handling, and storage of all chemicals and biohazards, and proper disposal of hazardous waste.
• Adhere to safety requirements, complete required safety and health training, and follow safe procedures.
• Maintain current training status prior to task execution and ensure method verification, qualification protocols, and investigations are performed appropriately.
• Demonstrate strong documentation and technical writing skills.
• Understand monitoring programmes and methods, conduct troubleshooting analysis, and stay knowledgeable of current regulations and scientific literature.

Skills

GMP knowledge

Quality focus

Team leadership

Technical writing

Documentation

Education

Bachelor's degree in Microbiology

Master's degree in Microbiology

Doctorate in Microbiology

Job description

Shift Schedule

Please note: This position is for Wednesday - Sunday, 12pm - 8pm.

Position Summary

Responsible for overseeing testing and support for the Microbiology Laboratory in support of a contract manufacturing biotechnology facility and process development. Responsibilities include laboratory support, program testing, reporting of results, development and execution of protocols and reports.

Program Areas

• 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

Key Responsibilities

• Plan and execute routine microbial laboratory work using technical discretion for program goals.
• Utilize technical expertise to execute and interpret experiments, including testing when required.
• Manage employee development and conduct detailed observations and intermediate data analysis.
• Serve as a qualified trainer for the Quality Microbiology team and provide training on programmes.
• Ensure proper labeling, handling, and storage of all chemicals and biohazards, and proper disposal of hazardous waste.
• Adhere to safety requirements, complete required safety and health training, and follow safe procedures.
• Maintain current training status prior to task execution and ensure method verification, qualification protocols, and investigations are performed appropriately.
• Demonstrate strong documentation and technical writing skills.
• Understand monitoring programmes and methods, conduct troubleshooting analysis, and stay knowledgeable of current regulations and scientific literature.

Minimum Requirements

• Bachelor of Science degree in a scientific discipline with a minimum of 4–5 years of technical management experience, or a Master’s degree with 3 years of experience, or a Doctorate in Microbiology with 1 year related experience and/or equivalent training.
• 0+ years of managerial experience.
• Knowledge of GMPs and biotechnology-derived product regulations.
• Ability to react to change productively and handle other essential tasks as assigned.
• Track record in the following areas:
  • Strong orientation for Quality and Customer Service
  • Demonstrated respect for individuals
  • Demonstrated contribution to science in appropriate area
  • High level of integrity and personal responsibility
  • Strong collaboration and team building skills

Benefits & Development

We offer employees a challenging, rewarding, and fast‑paced environment along with the opportunity for career advancement through the development of one’s technical skills. Employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce.