Microbiologist

Role Summary

The Microbiologist will join the Quality Controls Laboratory group to perform microbiological testing for manufactured products in compliance with SOPs and STPs, supporting testing and release of product. The role may involve 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 trouble shooting 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
• Preferred: Advance understanding of microbiology
• Preferred: Existing knowledge of FDA, USDA, EMA, and compendial requirements associated with Quality Control assay development and testing
• Proven project and time management experience including technical writing of protocols and reports

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
• Excellent verbal/written communication, organizational and interpersonal skills

Education

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

Additional Requirements

• Physical Position Requirements: Manual dexterity; ability to sit or stand at a laboratory bench; close vision; occasional sitting or reaching;
• Ability to work flexible hours, including weekends and overtime