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KBI Biopharma

CDMO delivering cell line development

Microbiology Specialist 1

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeDurham, NC, USANo salary listed

About the Job

Requirements

  • A Bachelor of Science degree in a scientific discipline with 5–7 years of technical management experience, or a master's degree with 3–5 years of experience, or a doctorate degree in Microbiology with 1–3 years of related experience and/or equivalent training.
  • Familiarity with current regulations and scientific literature.
  • Current training qualification before executing assigned tasks.
  • Ability to properly label, handle, and store chemicals and biohazards used in the laboratory.
  • Ability to label and dispose of hazardous waste appropriately and comply with laboratory safety requirements and required safety and health training.
  • Availability to work on-site full time, with at least 40% of work performed in the laboratory.

Responsibilities

  • Support microbiological programs and testing activities for processes, instruments, and equipment.
  • Ensure effective use of materials, equipment, and personnel while developing products and processes at high quality levels.
  • Execute assigned aspects of environmental monitoring programs, including air viable, total air particulate, and surface viable monitoring.
  • Execute assigned clean utility monitoring, including water sampling, bioburden, conductivity, total organic carbon, coliform, and nitrate testing.
  • Execute assigned compressed gas monitoring, including collection, air viable, total air particulate, Dräger tests, and specific identification tests.
  • Perform product testing, including bioburden, endotoxin, host purity, and non-host testing.
  • Support media release and laboratory activities.
  • Use technical discretion to execute and interpret experiments that contribute to program goals.
  • Perform testing when required.
  • Understand monitoring programs and methods and conduct troubleshooting analyses.
  • Develop and execute method verifications and qualification protocols, and conduct investigations appropriately.
  • Make detailed observations and perform advanced data analysis.
  • Train Quality Microbiology staff on programs as needed.
  • Execute and review routine microbiology laboratory work.

About the Company

KBI Biopharma

CDMO delivering cell line development

KBI Biopharma is a CDMO that accelerates the development of biological medicines by providing rapid cell line generation and process development for preclinical programs. It uses established mammalian and microbial expression systems (such as CHO K1, CHO S, CHO DG44, HEK293, and DXB11 E. coli) to create production cell lines and develop integrated manufacturing processes. Compared with competitors, it wins on speed, end-to-end capability, and flexibility across multiple platforms to move projects quickly from discovery to preclinical milestones for a diverse client base. Its goal is to reduce risk, shorten development timelines, and expand global access to life-saving biologic therapies.

Company size
1,001-5,000
Company stage
Late Stage VC
Total funding
$109.5M
Headquarters
Durham, NC
Founded
1996

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