Jane Forbes Email and Phone Number

Working within Contamination Control Division.

A centre of excellence for Biologics. The site supports process and product development with a strong focus on Biosimilars whilst working in the laboratories:*Gained extensive knowledge of microbial rapid methods, including Microseq and Endosafe MCS endotoxin system.*Completed a four month secondment into Molecular Biology department to support new product development.*Trained and coached new members of staff.*Fully participated in root cause analysis investigations and troubleshooting to improve quality and create consistency across the team.*Highly proficient user of laboratory databases including LIMS, Trackwise and Navision (purchasing system).*Performed verification of analytical data, checking for quality and accuracy of results.

A medical devices company providing a variety of wound care products. Working within a busy R&D laboratory I was involved in providing microbiology support for products in development. My key skills included:Identification of aerobic and anaerobic organisms using the Microseq.Antimicrobial Efficacy TestingMedia Preparation and use of autoclaves.Culture MaintenanceBioburden Testing

Working in the Microbiology Department I assisted with the transfer of the department to a new facility. The project involved writing and executing validation protocols for the technology transfer of all the laboratory methods and equipment.Major projects include disinfectant validation and implementation of a new microbiological media supplier.

The company provided a third party manufacturing and testing service. My key responsibilities were:Validation of microbial methods, following USP and ICH guidelines, for customers. Methods included: purity analysis, plasmid retention, endotoxin, bioburden and TVC by membrane filtration. Qualification of Biolog Identification System and BioWwhittaker Endotoxin system into the Microbiology Department. Line management of analysts seconded to the group to execute various validation projects. Provision of technical guidance and training to analysts within the department.Supporting manufacturing operations during fermentation contamination investigations.

Working for a small company enabled me to gain valuable experience through interaction with all departments across the business.My role involved environmental monitoring of clean areas, microbial analysis of in-process and final product samples including:• Endotoxin testing of in- process and water samples• Identification to species level of microbial contaminants from environmental and process samples.• Preparation and Maintenance of Working Cell Banks• Reviewing and revision of procedures to ensure compliance to cGMP. • Investigation of environmental excursions, and provision of solutions to reduce the number of excursions across site.• OOS and Deviation Report investigations

Rotation through the Microbiology Laboratories to gain extensive experience in the following areas:Identification to the species level of bacterial contaminants using API kits and the Vitek system.Preparation and maintenance of cell banks.Growth promotion of microbiological media.Environmental Monitoring of clean areas.TVC of in-process, final product and water samples by membrane filtration.Endotoxin testing using KQCL system and Gel Clot methods.Preparation of Media, and use of autoclaves