United States
- Performing technology transfer of mRNA drug product manufacturing process to CMOs (contract manufacturers) - Scale up of mRNA drug product manufacturing process - Factory acceptance testing of manufacturing equipment - Support of GMP mRNA drug product GMP manufacturing operations
- Commissioning and qualification of batch manufacturing system, installed in United Kingdom at CMO - CIP, SIP, and BULK process development of 200L batch manufacturing system in United Kingdom - Conceptual and detailed design of second version of aseptic 200L batch system - Technical support to manufacturing and validation
- Factory acceptance tests for vessels, manufacturing skids, and software packages (45L and 200L batch systems) - Mechanical/software commissioning of batch (45L and 200L batch systems) manufacturing system at CMO in the United Kingdom - Aseptic validation activities on 45L batch manufacturing system (thermal mapping, aseptic process simulation) - CIP, SIP, Bulk process development for scaled-up batch manufacturing system of sterile injectable drug (200L) - Process and P&ID design for continuous manufacturing system (600L); scale-up design from pilot scale to commercial scale
- Technology transfer activities including the transfer of bench-scale pharmaceutical processes to pilot and commercial scale manufacturing equipment - CIP and SIP process development for aseptic pharmaceutical processes - Executing mechanical, software, and automation factory acceptance tests of pharmaceutical manufacturing trains and individual components - Assisting in the writing of equipment and process validation documents
- Performing validation of botanical extraction, concentration, and granulation processes, with a concentration on the solid-dose tableting and soft-gel encapsulation unit operations. - Optimizing botanical granulations on new technology to meet and exceed manufacturability requirements. - Designing solid-dose compression experiments to determine material and process limits. - Working on multi-disciplinary teams to complete major projects, such as the transfer and/or implementation of new manufacturing processes.
- Operated pilot-scale extraction, concentration, and spray drying equipment. - Created and implemented changes to pilot-scale processes, resulting in improved process efficiency and operation. - Assisted in optimizing processing parameters in several unit operations. - Validated new botanical processing technology and processes.
- Preparing E. coli cell cultures for protein expression. - Purifying protein samples using Fast Protein Liquid Chromatography (FPLC). - Characterizing protein samples with SDS-PAGE gels, mass spectrometry, and dynamic light scattering. - Performing dialysis experiments to determine the pH–responsiveness of E2, a self-assembling protein.