The incumbent will evaluate and develop methods to rapidly detect and identify microbial contaminants. Microbial testing is performed to monitor facilities and clean utility systems and to verify that in-process materials are contamination free. Once methods for detection and identification are selected, the incumbent will work to develop those methods into assays that can be deployed in a cGMP quality control testing laboratory.
The incumbent may develop PAT applications other than rapid microbial methods. Candidates demonstrating flexibility to work with a wide variety of technologies and analysis techniques are preferred.
The incumbent will review literature, work with vendors, plan and execute experiments, analyze data and generate reports that document results.
When PAT methods are selected for implementation, the incumbent will create an implementation plan, generate and execute validation protocols, and manage change control.
The incumbent will regularly inform stakeholders of progress, facilitate meetings to drive alignment, and obtain approvals as necessary to advance the project.
The process context in which PAT applications are deployed may include mammalian cell culture, protein purification or final product formulation, filling and packaging. The incumbent may also develop applications for cell or gene therapy manufacturing processes.
* Education Requirements: PhD in Microbiology, Biochemistry or Molecular Biology
* Skill & Competency Requirements:
* Microbiological techniques
* DNA isolation and purification expert
* Knowledgeable of subcloning
* Western blotting
* Experimental design
* Nucleic acid isolation
* Plasmid synthesis
* Immunofluorescence assay
* Computational biology
* Amplification of Genomic DNA by Polymerase Chain Reaction
* Enzyme-Linked Immunosorbent Assay (ELISA)
* qPCR assay
Sthree US is acting as an Employment Business in relation to this vacancy.