The Microbiologist will perform routine environmental monitoring in cleanroom areas under ISO 5 and ISO 7 conditions to support status of manufacturing facilities in both the drug substance and drug product area. The Microbiologist will assist in trending of environmental monitoring data. Create written methods and perform microbiological testing such as endotoxin, bioburden and sterility based on USP. Write method qualification protocols, reports and SOP(s) for microbiological operations. Generate valid test results and report results for the assigned Development and GMP testing in a timely and compliant manner.
Our biotech clients seek microbiologists who are detail driven, with strong environmental monitoring experience, statistical and analytical skills and are comfortable working in a fast-paced, start-up environment. The microbiologist will work in a collaborative scientific group, so flexibility is important. Our companies offer accelerated career growth potential, and excellent benefits. We have many opportunities - all with biotech companies seeking cutting edge scientific talent.
typical roles and responsibilities for Microbiologist
- Perform environmental monitoring including non-viable air, viable air and surface samples
- Perform microbiological testing such as endotoxin, bioburden and sterility testing for development and GMP samples, including in-process samples
- Trending of environmental monitoring data
- Create and/or revise microbiological methods and SOP(s) for microbiological operation
- Assist in improving QC systems, including revising QC system or microbiological method SOPs
- TOC testing and raw materials testing
Requirements for the Microbiologist:
- Bachelor's degree in biology, molecular biology, biochemistry, or a related scientific discipline.
- 3+ years of professional quality control microbiology - QC - experience in GMP biopharmaceutical or biotechnology industry
- Experience with endotoxin, bioburden and sterility testing
- Working knowledge of GMP and ISO regulations
- Working knowledge of commissioning of ISO 7 and ISO 5 facilities
- Strong aseptic technique
- Ability to work effectively with flexibility in a highly collaborative environment
- The ability to manage multiple competing priorities and work in a fast-paced start-up environment
- Excellent communications skills, oral, written and electronic
- Strong statistical and analytical skills with excellent attention to detail.
Salary range for Microbiologist