Plan-les-Ouates, Geneva, Switzerland
Management of USP and DSP experts for the Tech Transfer of clinical biologic programs from Process Development to 2000L GMP Manufacturing scale - Creation of BOM, Creation of Process Flow Diagram, Customer interaction, assessment of the product impact during deviation, Material specification creation, Campaign summary report, Process design to optimize manufacturing and cost, Deviation author and reviewer
Operational oversight and subject matter expertise of drug substance commercial manufacturing process - Review and technical approval of manufacturing documents (Process Description, Deviation, Change Control), technical review of QA documentation from CMOs, review of APQR and CPV Responsible for process characterization study to support DS process validation (PPQ) - Bioreactor screening, set-up of scale-down model, tech transfer, review of FMEA and gap analysis, transfer of upstream and dowstrean processes to CMOs and GMP documentation review prior to PPQ campaign Leading cell line development projects for mAb intended for therapeutic purposes - Ensure process transfer to CMO via regular TCs, visits, GMP documentation review, coordination with DSP, analytical and project management team Leading the development of a new upstream platform intended for GMP manufacture -USP representative for the CMO selection process, bioreactor cell culture optimization, Pre-clinical pilot scale production up to 200L in single-use bioreactor
Upstream process and technological development and optimization -Development of an abridged fed-batch model in 24wpl, implementation of a single cell printing device, optimization of shake flask fed-batch screening throughput, implementation of a bioanalyzer Leading the development of a new upstream platform intended for GMP manufacture -USP representative for the CMO selection process, bioreactor cell culture optimization, Pre-clinical pilot scale production up to 200L in single-use bioreactor Leading cell line development projects for mAb intended for therapeutic purposes - Transfection, 24wpl screening, subcloning, cell banking, shake-flask fed-batch screening, evaluation in small scale bioreactor ; coordination with DSP, analytical and project management team Pre-clinical pilot scale production up to 200L in single-use bioreactor Quality assurance activities -Implementation and revision of SOPs, records, protocol for equipment validation (IQ, OQ, PQ) Operational project management -Planning of upstream activities and resources (daily and long-term schedule), report writing, troubleshooting expertise, equipment selection, budget preparation Regular communications with CMOs & suppliers and during internal and external meetings -Data presentation to the scientific and senior management team, presentation during conference, review of upstream GMP documentation Resource management - Management a team of three Technicians and Assistants
Leading cell line development projects for mAb intended for therapeutic purposes Leading the development of a new upstream platform intended for GMP manufacture - Bioreactor cell culture optimization, Pre-clinical pilot scale production up to 200L in single-use bioreactor Responsible for the evaluation and implementation of disposable stirred and airlift bioreactors - Bioreactor screening, development of a scale-down model of a GMP-scale airlift bioreactor for a process characterization study, set-up of small-scale stirred bioreactor