Microbiologist

Role Summary

Microbiologist responsible for performing microbiological laboratory procedures to support testing and release of product within the Quality Controls Laboratory. Requires expertise in SOPs/STPs, with additional skills in microbial assay validation, troubleshooting, training, project management, and report writing.

Responsibilities

• Perform complex routine laboratory testing independently
• Interact with interdepartmental customers such as Manufacturing, Regulatory, and Quality Assurance
• Perform laboratory testing associated with transfer projects
• Perform troubleshooting and problem solving for routine tests and processes
• Demonstrate expertise and participate in laboratory responsibilities, including training, paperwork review and approval and laboratory investigation support
• Assist supervisor with daily decision-making using data, good judgment, and experience
• Work with Maintenance and Engineering to improve laboratory and equipment operation
• Proceduralize processes using standard work concepts
• Participate in outline reviews as a SME reviewer, provide SAP data extracts and perform routine data analytics using basic statistical analysis
• Provide support for routine laboratory activities outside of testing including LEAN projects and Critical Reagent Management

Qualifications

• B.S. or equivalent in Biological Sciences or closely related field and 5 - 7 years' experience in a microbiological laboratory
• Experience performing / troubleshooting / developing microbiological assays
• Exceptional Organizational, Communication and Interpersonal skills
• Understanding of Biological and Chemical Processes common to Quality Control Testing
• Understanding of Biological Regulatory Requirements and Licensure Process
• Self-starter, able to prioritize work and work efficiently with minimal supervision
• Complete calculations using basic math
• Understand metric system and basic statistics
• Ability to solve practical problems with a variety of concrete variables
• Ability to make logical decisions concerning team and department issues
• Ability to make laboratory decisions in absence of supervision
• Ability to recognize product quality issues based on company guidelines
• Ability to train colleagues on both basic fundamentals and technical aspects of microbiological assays

Skills

• Microbiological assay development and troubleshooting
• Data analysis and basic statistical methods
• Technical writing of protocols and reports
• Training and mentoring
• Laboratory instrumentation operation and maintenance coordination

Education

• B.S. or equivalent in Biological Sciences or closely related field

Additional Requirements

• Physical position requirements include manual dexterity, ability to sit or stand at a bench, close vision, occasional reaching, and ability to work flexible hours including weekends and overtime