•Proficient in isolating and culturing various cell lines using both open and closed system aseptic processing techniques. Experienced with iPSC’s, hMSC’s, PANC’s, MASC’s, NHF’s and NHK’s•Proficient in writing of SOP’s, Error Prevention Documents and Procedural Work Instructions.•Experienced with conducting technical investigations and evaluation of environmental excursions. •9+ years GMP and GLP Experience in both ISO and EU class environments. Proficient in working in (BSL) 2 and… Show more •Proficient in isolating and culturing various cell lines using both open and closed system aseptic processing techniques. Experienced with iPSC’s, hMSC’s, PANC’s, MASC’s, NHF’s and NHK’s•Proficient in writing of SOP’s, Error Prevention Documents and Procedural Work Instructions.•Experienced with conducting technical investigations and evaluation of environmental excursions. •9+ years GMP and GLP Experience in both ISO and EU class environments. Proficient in working in (BSL) 2 and 3 environments.•Experienced with creating and executing training systems. Show less

•Support Aseptic Process Validations by performing environmental monitoring (EM), screening and verification of fill-samples, and GMP documentation.•Supports cleaning validations by performing environmental monitoring (EM), screening and counting fill-samples, and related documentation.•Performs plate enumeration and water sampling.•Performs assays such as growth promotion qualification and bio burdens.•Perform support functions such as scheduling, material planning and… Show more •Support Aseptic Process Validations by performing environmental monitoring (EM), screening and verification of fill-samples, and GMP documentation.•Supports cleaning validations by performing environmental monitoring (EM), screening and counting fill-samples, and related documentation.•Performs plate enumeration and water sampling.•Performs assays such as growth promotion qualification and bio burdens.•Perform support functions such as scheduling, material planning and ordering, document creation and editing, development and execution of training.•Prepares trend/data analyses reports. Writing of SOP’s and CAPA investigations.•Creation, Revisions, and Review of Process Validations.•Assisted in the Sterility Department with GMP Product & Lot Release Testing including Growth Promotion Qualification, Microbial Bioburden Testing, Bacteriostasis and Fungistasis Assays and BacT/Alert Sterility Testing. Show less

•Perform and Support daily production tasks such as isolations, EM, Cell Counts, feeds, passages, and harvest (Disassociation/Formulation/Filling/Cryopreservation) of various cell types.•Responsible for conducting manufacturing evaluations of all Cell Therapy environmental and personnel excursions. Providing identification of root causes and resolutions including investigations, development and execution of technical protocols and CAPA’s.•Experienced in creation of and writing of SOP’s,… Show more •Perform and Support daily production tasks such as isolations, EM, Cell Counts, feeds, passages, and harvest (Disassociation/Formulation/Filling/Cryopreservation) of various cell types.•Responsible for conducting manufacturing evaluations of all Cell Therapy environmental and personnel excursions. Providing identification of root causes and resolutions including investigations, development and execution of technical protocols and CAPA’s.•Experienced in creation of and writing of SOP’s, Error Prevention Documents and Procedural Work Instructions. •Perform support functions such as scheduling, material planning and ordering, document creation and editing.•Development and execution of GMP ISO/EU manufacturing training qualifications.•Execution of equipment cleaning and maintenance.•Review of GMP Documentation.•Problem solving and corrective actions. Show less