**Must be able to commute to lab in Morrisville, NC
This is a mid-senior level role for a Microbiologist with experience in Biopharma. Experience with Endotoxin, Bioburden, Sterility, and/or environmental monitoring required.
Under the supervision of other scientists, the Microbiologist works on problems of limited scope where analysis of data evaluation of identifiable factors. The Microbiologist carries out activities in support of the manufacturing of pharmaceuticals products. These activities include compendial microbial testing of raw materials, in process materials, and finished products within scheduled timelines.
* With supervision, carries out analytical activities in support of the manufacturing of pharmaceutical products under supervision of other scientists in the department. These activities include raw material testing, in process testing, finished product testing, sample analysis, and physical evaluation of products.
* Method development and/or method validation projects are within the scope of this position.
* With supervision, provides GMP Testing support for quality assurance of products. This includes assisting in writing protocols and reports; ordering lab supplies.
* With supervision determines general approaches for assigned projects, then plans and executes work independently with minimal supervision.
* Proficiency in Quality Systems such as Trackwise and able to execute steps in laboratory investigations.
* Provides training, instruction and guidance to junior level scientists.
* Perform environmental sampling and testing and perform microbial sampling testing activities within scheduled timelines.
* Maintain notebooks and files compliant with current GMPs and SOPs.
* 4-8 years of experience in microbial testing experience in the pharmaceutical industry.
* Working knowledge and application of scientific principles and techniques.
* Strong background in Microbial limits testing, Environmental Monitoring, and Identification of Microorganisms.
* General knowledge and experience microbiological testing requirements required.
* Working knowledge of cGMP regulations.
* Experience in Endotoxin, Sterility (bacteriostasis/fungistasis)
* Bioburden experience and environmental monitoring
* Must have experience within pharma/biopharma
* Ability to execute procedures and methods and comply with all regulations.
* Ability to lead small team projects.
* Has developed troubleshooting and problem solving skills.