Microbiology Senior Associate

KBI Biopharma•Durham, NC

1d•Onsite

About The Position

The Microbiology Senior Associate will be part of the Microbiology Department responsible for the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities includes laboratory support, program testing, reporting of results, development and execution of protocols and reports. 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 It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory/facility for a minimum of 60% time daily.

Requirements

Bachelor’s/Master’s degree in Microbiology, Biology or related technological field of science.
Minimum years of experience 3 – 4 years of experience or MS and 2 years of experience or PhD and 0 years of experience.

Responsibilities

Executes routine Microbial Laboratory work.
Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals.
Strong understanding of monitoring programs and methods and conducts troubleshooting analysis.
Makes detailed observations and carries out intermediate data analysis.
Strong documentation and technical writing skills.
Qualified trainer for the Quality Microbiology team.
Performs training for staff on programs as needed.
Develop and execute method verifications and qualifications protocols and investigations are performed appropriately.
May execute testing when required.
Maintains current state of training prior to execution of tasks.
Knowledge of current regulations and scientific literature.
Strong working knowledge of sampling equipment and testing instruments.
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.