David Edwards Email & Phone Number

Berne, Switzerland

Sydney, New South Wales, Australia

• Worked at this start-up company using an exciting novel plasma fractionation technology with a focus on supporting and improving processes through further development, training operators, improving documentation and by executing steps within production• Implemented process and quality improvements for existing tangential flow filtration (TFF) system and worked on the qualification, testing and initial use of an AKTA Readyflux TFF system including writing UNICORN methods• Improved… Show more • Worked at this start-up company using an exciting novel plasma fractionation technology with a focus on supporting and improving processes through further development, training operators, improving documentation and by executing steps within production• Implemented process and quality improvements for existing tangential flow filtration (TFF) system and worked on the qualification, testing and initial use of an AKTA Readyflux TFF system including writing UNICORN methods• Improved viral filtration process; communicated viral filter validation requirements to a third party and secured consumables/product for validation runs; and tested demo viral filtration skid on site• Prepared for installation and usage of a new aseptic filler including attending FAT, ordering consumables, verifying utility requirements would be met in facility upgrade• Collaborated with multiple functional areas especially QA, QC and R&D to ensure successful process engineering were achieved• Authored controlled documentation for engineering and production areas• Reviewed numerous internal controlled documents and external documents including batch records, work instructions, SOPs, qualification and engineering specification documentation• Collaborated with vendors to test consumables, ensure documented recommendations were followed and that consumables and equipment were operated within their validated range • Managed change controls, deviation reports and CAPAs Show less

Brisbane, Queensland, Australia

• Lead operation of bioreactors and harvest via depth filtration for manufacturing runs including batches for the UQ/CEPI COVID vaccine and an antibody for compassionate use in persons exposed to the Hendra virus• Authored documentation for use and batch execution using bioreactors and improved other upstream processing (USP) documentation• Worked on technology transfers to Thermo Fisher Scientific (Patheon), Cytiva and CSIRO• Assisted lead USP scientist with mammalian cell culture… Show more • Lead operation of bioreactors and harvest via depth filtration for manufacturing runs including batches for the UQ/CEPI COVID vaccine and an antibody for compassionate use in persons exposed to the Hendra virus• Authored documentation for use and batch execution using bioreactors and improved other upstream processing (USP) documentation• Worked on technology transfers to Thermo Fisher Scientific (Patheon), Cytiva and CSIRO• Assisted lead USP scientist with mammalian cell culture including: vial thawing and banking; maintenance and scale up; stable and transient transfections; feed studies; small scale productions; enriched pool selection and clonal isolation; and harvest (using centrifugation and depth filtration)• Lead the selections and installation of new equipment (Bioprofile Flex2, 10L XDR bioreactor and WAVE25 bioreactor) and the maintenance of existing equipment for bioreactor room• Arranged utility (gas and electricity) improvements for bioreactor room• Ordered and maintained consumable stocks for standard cell culture work and bioreactor runs• Trained newer staff on upstream processes and bioreactor operation• Created excel based visual management tool for activity scheduling and worked with the NBF team to improve and standardise communication of project information• Organised a large shipment of donated-equipment from closed facility in India to the Queensland and Victorian nodes of the NBF Show less

Brisbane, Queensland, Australia

• Worked on Upstream Processing (USP) team at this CDMO to scale up, maintain, then harvest CHO cultures at 500 and 2000L scales using single-use processing technologies for various clients• Lead execution of upstream processing steps (cell thaw; scale up through shake flask, WAVE bioreactors and single-use stirred tank bioreactors; preparation, inoculation, feeding and monitoring fed-batch production bioreactors at 500 and 2000L scale; harvest via depth then 0.2um filtration)•… Show more • Worked on Upstream Processing (USP) team at this CDMO to scale up, maintain, then harvest CHO cultures at 500 and 2000L scales using single-use processing technologies for various clients• Lead execution of upstream processing steps (cell thaw; scale up through shake flask, WAVE bioreactors and single-use stirred tank bioreactors; preparation, inoculation, feeding and monitoring fed-batch production bioreactors at 500 and 2000L scale; harvest via depth then 0.2um filtration)• Maintained, troubleshooted and cleaned process and analytical equipment (cell counter and metabolite analyser)• Authored MBRs based on technology transfer reports and updated MBR templates, SOPs and other controlled documentation• Trained new hires on upstream processes and documentation• Wrote precise comments, participated in deviation investigations and executed corrective and preventative actions• Identified and made process and quality improvements at the Brisbane and St. Louis sites• Brought new consumables into the quality management system• Assisted and ensured site procedures and GDP were followed during IQ/OQ of new 50L and 500L bioreactors Show less

Brisbane, Queensland, Australia

• Worked on the Media and Buffer Preparation (MBP) team to deliver multiple solutions/day for upstream and downstream operations including final formulation using single use technologies at up to 1000L scale• Learnt and maintained compliance with all SOPs• Completed documentation as per ALCOA+ principles• Raised process issues and improvement opportunities with management• Dispensed raw materials and verified balances• Prepared solutions including performing additions… Show more • Worked on the Media and Buffer Preparation (MBP) team to deliver multiple solutions/day for upstream and downstream operations including final formulation using single use technologies at up to 1000L scale• Learnt and maintained compliance with all SOPs• Completed documentation as per ALCOA+ principles• Raised process issues and improvement opportunities with management• Dispensed raw materials and verified balances• Prepared solutions including performing additions, mixing, online/offline testing and filtration• Installed, made aseptic connections and aseptic disconnections for single-use bioprocess containers (BPCs)• Performed automated filter integrity testing• Assembled and autoclave sterilised manifolds using validated cycles Show less

Brisbane, Queensland, Australia

I was employed as a university tutor supporting tutorials and practicals during the final three semesters of my degree. I explained concepts from lectures for students and helped them apply these to new problems. As well as time spent providing support in class, I provided support by answered questions through online course forums and by marking and providing feedback on mid-semester assessment items.This was a very enjoyable experience and I was encouraged students' readiness to ask… Show more I was employed as a university tutor supporting tutorials and practicals during the final three semesters of my degree. I explained concepts from lectures for students and helped them apply these to new problems. As well as time spent providing support in class, I provided support by answered questions through online course forums and by marking and providing feedback on mid-semester assessment items.This was a very enjoyable experience and I was encouraged students' readiness to ask questions and the positive feedback I received.Tutored Courses: Semester 2 2016 - Reaction Engineering (CHEE3005) Semester 1 2016 - Chemical Thermodynamics (CHEE3003) Semester 2 2015 - Engineering Thermodynamics (ENGG1500) Show less

I undertook a summer research project on the rheology of mozzarella cheese. This included:• Preliminary testing to assess applicability of available equipment,• Performing literature search on rheological properties of mozzarella and similar cheeses,• Replicating numerous results from literature,• Modelling the elongational behaviour of mozzarella cheese, • Presenting my work to the two affiliated research groups.

Bachelor Of Engineering (Honours), Dual Major In Chemical And Biological Engineering, First Class Honours With Gpa Of 6.5

This degree required at least four years of full time study. Initial courses provided a background in: mathematics; chemistry; biology.

Queensland Certificate Of Education (Qce), Overall Position (Op) Of 2

Authority Subjects were: - English - Mathematics B - Mathematics C - Chemistry - Physics - German (grades 10 and 11) - German Extension.