Open to opportunities in and around Sydney NSW and southeast QLD.

• Assembled/formulated and completed batch records (BR) for TGA-registered and Research Use Only molecular in vitro diagnostic (IVD) high throughput multiplexed quantitative PCR (qPCR) kits and components as per ISO 13485 and the internal quality management system (QMS)• Operated automated equipment, including Tecan Freedom EVO, Hamilton Microlab STAR, and Integra VIAFILL for reagent dispensing, and Lab Services PlateButler for assay plate foil-sealing• Rapidly marshalled primer mix components for Production laboratory staff batch formulations• Monitored the temperature and relative humidity of laboratory spaces, drying cabinets, and cold storage chambers via data loggers, and reported out-of-specification/trend (OOS/T) events• Prepared intermediate materials required for production processes accurately and consistently

• Adhered to a rigorous culture of safety, continuous improvement, and compliance with multiple regulatory bodies (including the TGA, NMPA, and Health Canada), the PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products Annex 1, and the internal QMS in a sterile pharmaceutical manufacturing and microbiological quality control (QC) testing environment• Performed QC sterility testing of finished respiratory (direct inoculation) and injectable (membrane filtration) product samples within a Grade B cleanroom under CCTV surveillance• Continuously conducted and maintained availability of all consumable goods for QC kinetic chromogenic bacterial endotoxin testing (BET) of facility water samples and BET cartridge batch verifications using the Charles River Laboratories Endosafe Nexus automated platform• Performed QC membrane filtration microbial limits testing (MLT) of bulk medicinal samples• Carried out viable and non-viable environmental monitoring (EM) of all graded facilities and compressed gas lines, and qualification, data back-up, and maintenance of all EM equipment• Accurately received, inspected (via light box), sorted, and stored various finished product and media fill samples into the correct formats and storage conditions for subsequent QC testing• Participated in the deviation, nonconformance investigation, root cause analysis, and corrective and preventative action processes by liaising with Microbiology QC and Compliance Specialists• Used multiple electronic laboratory information (LIMS) and document management systems

• Assisted with formalising live biotherapeutic clinical trial product manufacturing procedures and BR forms to be more in line with the PIC/S Guide to GMP for Medicinal Products Annex 13• Performed QC microbial enumeration testing of lactic acid fermenting starter culture samples• Facilitated and tracked the outsourced QC MLT of intermediate and finished product samples• Reviewed/compiled all microbiological QC testing data and investigated OOS/T growth events• Received, inspected, reviewed certificates of analysis of, and released Production raw materials

• Carried out contract sterile biomanufacturing of multiple autologous and allogenic Phase 1 clinical trial cell therapies in compliance with the Australian Code of GMP for Human Blood and Blood Components, Human Tissues, and Human Cellular Therapy Products in TGA-assessed Grade B cleanrooms with good aseptic, mammalian cell culture, and microscopy techniques• Commissioned cleanrooms for biomanufacturing processes, including the safe handling and removal of biohazardous wastes, cleaning, restocking of laboratory consumables and personal protective equipment, adjusting and calibrating incubator and refrigerator set points, and ensuring all other capital equipment required for processing was made available and calibrated• Provided peripheral support to operations, including timely delivery of cold chain critical cells, cytokines, and media, controlled rate freezing and liquid nitrogen banking of vialled products, and liaising with Supply Chain to ensure availability of necessary goods ahead of processes

• Assembled/formulated/dispensed, completed BRs for, and routinely took inventory of TGA-registered, clinical trial, and Research Use Only molecular IVD high throughput clinical sample processing and multiplexed qPCR kits and components as per ISO 13485 and the internal QMS• Planned and carried out pathogenic DNA and RNA extractions/purifications from clinical sample matrices and commercially quantitated stocks using Thermo Fisher KingFisher Flex and Hamilton/Thermo Fisher NIMBUS Presto automated platforms, used the materials to conduct various Bio-Rad CFX qPCR QC tests on intermediate and finished products, analysed the data using Microsoft Excel, and thoroughly documented and reported all testing details and results• Scheduled, planned, and conducted routine stability studies and occasional customer complaint investigations of finished product batches using the monday.com project management software• Performed and led the initiative to formalise the receipt, preparation, and QC testing of primers (optical density quantitation) and probes (qualitative melt analysis) used for all laboratory operations, focusing on interdepartmental communication and documentation standardisation• Drafted and executed tests as per process validation protocols for the upscaling of existing and new product formats in rapid response to the sudden SARS-CoV-2 pandemic market demand• Supported the Research and Development (R&D) department on various projects, including the characterisation of newly acquired infected human clinical samples used by all laboratory staff• Transferred materials and products between the warehouse, production, and laboratory sites

• Conducted microbiological R&D experiments with raw materials and QC MLT of finished products in an ISO 13485 certified facility for the design and manufacture of disinfectants• Prepared and maintained inventory of microbial stock cultures and microbiological media• Generated certificates of analysis for products, including QC testing results and specifications

• Completed risk assessment reports to determine the appropriate extent of GMP QC MLT for various products based on their manufacturing processes, intended uses, and recipients as per the Australian Register of Therapeutic Goods, MLT method validation and water activity testing results, and the applicable TGA Therapeutic Goods Orders encompassing the harmonised acceptance criteria of the British (BP), European (Ph. Eur.), and US (USP-NF) pharmacopoeias• Performed QC MLT of pharmaceutical raw material and finished product samples, Gram stained and identified (via microscope) recovered OOS/T growth, and entered testing data into LIMS• Internally audited the testing documentation of other Microbiology staff and reported findings• Served as a liaison between the Microbiology laboratory and Production for procuring samples• Trained new staff on LIMS data entry, document filing, equipment logbook review, and cleaning

• Followed and revised protocols and BR forms for the assembly/production/dispense of bacterial cloning kits and components, including electro- and chemically-competent E. coli cells and plasmid vectors and positive control inserts as per ISO 9001, 13485, and the internal QMS• Qualitatively and quantitatively analysed DNA using QIAGEN extraction/purification kits, Thermo Fisher Qubit fluorometer, Eppendorf BioSpectrometer spectrophotometer, and Bio-Rad MicroPulser electroporator, CFX qPCR thermocycler, and Gel Doc gel electrophoresis imager• Assisted in the development of a novel C. difficile point-of-care (POC) loop-mediated isothermal amplification (LAMP) molecular IVD assay, including participation in the validation of an enzyme activity unit determination assay to optimally calibrate batch reagent formulations• Planned and executed experiments on the LAMP assay in conjunction with its prototype POC medical device platform and single-use components, including limit of detection/quantitation assessments, repeatability/reproducibility tests, and potentially interfering substances studies• Independently determined the optimal heat, time, and pressure parameters for oven-drying and foil-sealing reagent-filled functional LAMP microfluidic assay cartridges, and manufactured and ensured their ready availability for use in all applicable R&D product development projects• Safely handled and tested several infected human clinical sample types in a PC2 environment• Presented R&D results in cross-functional team meetings using PowerPoint to other scientists and stakeholders, and provided assay process demonstrations to prospective business partners• Performed various laboratory maintenance tasks, including calibrating qPCR optical detection systems, defrosting, cleaning, and organising cold storage chambers, and preparing reagents• Participated in scientific community outreach opportunities as a good company representative

• Maintained a steady, coordinated workflow with colleagues to keep all client GMP projects on schedule whilst adhering to USP-NF, Ph. Eur., Japanese Pharmacopoeia, and FDA regulations• Received and qualified purchased microbiological media and lyophilised ATCC microorganisms • Performed numerous microbiological QC tests on various pharmaceutical samples, including isolator sterility testing, MLT, container closure integrity testing, kinetic chromogenic and gel-clot BET, and method validation testing of new sample types and formats for each test category• Aseptically weighed and aliquoted pharmaceutical samples for further study in the organisation• Drafted/revised quality documents, adhered to ALCOA+ documentation standards, authorised test reports, entered data into client LIMS, and responded to QA findings via the internal QMS• Conducted routine cleaning and aseptic EM of biosafety cabinets, an ISO Class 8 cleanroom, and other general laboratory areas, and compiled the results in a customer-facing report annually

• Aided in the preliminary determination of the species belonging to the microbiome of the Mountain Pine Beetle (Dendroctonus ponderosae Hopkins, MPB) by categorising and isolating recurring unique microbial colony morphologies derived from field MPB samples, extracting isolate DNAs and subjecting them to restriction digestion and agarose gel electrophoresis, and comparing the fingerprinting results with those of metagenomic analyses performed in parallel• Prepared, read, and analysed the results of a series of bioassays involving confirmed MPB microbiome species, fungi present in MPB pine tree habitats, and pine terpenoids to emulate the ecosystem of these organisms and draw conclusions about their hypothesised symbioses• Maintained and quantitated (via haemocytometer and microscope) bacterial cell cultures and fungal spore suspensions to ensure inoculation consistencies across multiple bioassay setups• Presented experimental results and analyses at weekly laboratory meetings to researchers

• Prepared and maintained steady inventories of various sterile microbiological media, sterile and depyrogenated glassware, and nuclease-free consumables for all laboratory researchers• Routinely mixed and changed out the bleach solutions for used glassware receptacles, and properly autoclaved and disposed of biohazardous wastes generated by the laboratory• Assisted researchers with experiments in various capacities as needed, including counting colonies, plating media, aliquoting buffers, and performing serial cell culture sample dilutions