Vismay Patel Email & Phone Number

Toronto, Ontario, Canada

• Documented change control (tech transfer), Issue review, Investigation report.• Routinely performed environmental for cleanroom grade A and B controlled and skilledin performing aseptic process.• iPSC project: cell thaw, feed, passage, harvest, cell banking• K562: cell thaw, feed, passage, harvest, cell banking• HEK 293 project: cell thaw, expansion, passage, transfection, harvest.• TFF filtration and UF/DF process using AKAT ready and Repligen KrossFlo system,ColumnChromatography using AKTA pilot.• Trained team member in GMP unit operations.• Assisted with validation of equipment as well as documentation of related to it likeImpact assessment and User requirement specification (URS).• Performed risk assessment, Material safety sheet (MSS) and process gap analysis.

Mississauga, Ontario, Canada

● Operate equipment like Bioreactor, Incubator, Bio safety Cabinet (BSC) / Biocontainment hood , Homogenizer, TFF skids (UF/DF skids, Clarification skid), Chromatography skids (AKTA, OPTEK), Nanofiltration system.● Support manufacturing operations including Thaw, Cell Expansion –Shake Flask, Clarification, Concentration, Diafiltration, and Centrifugation.● Perform CIP (Clean-in-place) / SIP (Steam-in-place) of the mobile & immobile tanks. Operate Lauda Heater Chiller for temperature control and adjust pressure using compressed air system or air cylinder.● Participate in Formulation of Therapeutic Protein Products. Support in Tech transfer, scale up from lab scale to GMP full scale batch.● Perform Pre line clearance and Post line clearance. Receive components and material parts for the batch execution as per Bill of Materials (BOM). ● Environmental monitoring, Obtain Rinse/Swab samples and submit to QC department for checking TOC and Bioburden.● Participate in drafting and execution of Process/Cleaning validation Protocol and mixing study. After completing Protocol, Document summary report. ● Document and record all necessary information and data like observations and test results in Batch Production Record (BPR) and logbook.● Review and update SOPs, BPR and logbooks in accordance with change control as per GMP guidelines. ● Investigate the deviations incident and assist in writing the DR, CAPA and Change control. ● Maintain Housekeeping Standard and Keep production area in a tidy, GMP manner according to 5S guideline.

Toronto, Ontario, Canada

• Accurately performed duties in accordance with SOP, GMP, MBR, Environmental, Health & Safety procedures, Equipment Manuals and working instructions.• Accurately completed all GMP documentation in their area of responsibility.• Notified Supervisor of departures from procedure, product quality issues, safety incidents perform PSS entries• Dismantle, clean, assemble and sets-up processing equipment/rooms according to the equipment manuals and Working Instruction• Ensured the proper selection, care and use of tools, parts, and equipment• Prepared the necessary documents, including labels, logbooks, etc.• Effectively operated equipment and able to identify issues in a timely manner and escalates to the appropriate level for resolution.

Toronto, Canada Area

● Ensured all components / materials are received from warehouse and staged before batch execution.● Completed production related documentation like logbooks and batch sheet.● Responsible for ensuring all the equipment are cleaned as per the require standards.● Maintain MAL’s stocks and order supplies as needed and Stages buffers and raw material as required by process step.

Biotechnology, Biotechnology

Biotechnology

Bachelor Of Biotechnology, Biotechnology

Activities and Societies: Cricket tournament Bachelor in Botechnology