In this critical role you will p erform laboratory work in a cGMP manufacturing setting, primarily working with iPSC cell culture and differentiation, following bio-manufacturing procedures and manufacturing schedules to facilitate on-time delivery of high-quality finished products. Our Mio Manufacturing Specialists maintain safe and clean work environment by following current good manufacturing practices ( cGMP ), and standard operating procedures; complying with legal regulations; monitoring environment. Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs as required. FUJIFILM Cellular Dynamics, Inc. (FCDI) is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living.
Essential Job Functions Performs work in a cGMP setting, aseptic techniques, primarily working with iPS cell culture and differentiation, following SOPs, Manufacturing Procedures and manufacturing schedules to facilitate on-time delivery of high-quality finished products. Maintains laboratory standards to include but not limited to monitoring status, routine maintenance, and raw material inventories using ERP system. Runs in-process samples and reports in-process data in MPs, FORMS or Spreadsheets. Recommends and updates bio-manufacturing procedures, as required. Reviews and analyzes in-process and QC data to identify trends and key process parameters to troubleshoot and resolve trends in bio-manufacturing processes. Maintains a safe and compliant work environment. Participates on Technical Transfer teams. Basic SAP/Database skills Other job functions as assigned. Qualifications Bachelor's degree in cell biology, molecular biology, biochemistry or related technical field, or an Associate degree with a Biotech/Cell Culture certificate or equivalent in a comparable field of study or equivalent experience. Demonstrates ability to perform the following: Works in a cleanroom or lab for extended periods of time including repetitive hand motion. Works with clearly labeled hazardous materials – following all safe handling procedures Performs staging and stocking of raw materials and consumables Learns task prioritization and time management skills Works at computer for extended periods of time Wear standard cleanroom garment and/or laboratory personal protective equipment Occasionally lift 50 pounds Work a few hours approximately every third weekend. EEO/AGENCY NOTES
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
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