Nicholas Klausner Email & Phone Number

New Jersey, United States

Philadelphia, Pennsylvania, United States

• Manufacturing of adherent and suspension master/working cell banks and CAR-T cell therapy.• Executing manufacturing process for clinical therapies• Lead and perform procedures in processing suite in accordance to manufacturing batch records and standard operating procedures.• Train personnel on standard operating procedures in accordance with current good manufacturing practices (cGMP) and good documentation practices (GDP).• Authoring and revising documentation, including batch records and standard operating procedures, to support manufacturing processes• Lead the Manufacturing training team to develop and enrich up incoming technicians.• Developed and implemented batch records, change controls, SOP’s, and validation documentation• Use of support systems (LIMS, BMRAM, REES, MasterControl)

• Manufacturing of adherent and suspension master/working cell banks and CAR-T cell therapy.• Executing manufacturing process for clinical therapies• Lead and perform procedures in processing suite in accordance to manufacturing batch records and standard operating procedures.• Train personnel on standard operating procedures in accordance with current good manufacturing practices (cGMP) and good documentation practices (GDP).• Authoring and revising documentation, including batch records and standard operating procedures, to support manufacturing processes• Assist in leading the Manufacturing training team to develop and enrich up incoming technicians.• Developed and implemented batch records, change controls, SOP’s, and validation documentation• Use of support systems (LIMS, BMRAM, REES, MasterControl)

Philadelphia, Pennsylvania, United States

-Manufacturing of adherent and suspension master/working cell banks and CAR-T cell therapy.-Lead and perform procedures in processing suite in accordance to manufacturing batch records and standard operating procedures.-Train personnel on standard operating procedures in accordance with current good manufacturing practices (cGMP) and good documentation practices (GDP).-Authoring and revising documentation, including batch records and standard operating procedures, to support manufacturing processes.-Assist in leading the manufacturing training team to develop and enrich up incoming technicians.-Use of support systems (LIMS, BMRAM, REES, MasterControl).

Philadelphia, Pennsylvania, United States

-Manufacturing of adherent and suspension master/working cell banks and CAR-T cell therapy processing.-Perform procedures in accordance with current good manufacturing practices (cGMP) and good documentation practices (GDP),-Authoring and revising documentation, including batch records and standard operating procedures to support manufacturing practices as well as lot initiation in preparation for processing.

Glassboro, New Jersey, United States

As part of a lab team, conducted experiments such as the synthesis of nitrones from hydroxylamines and carbonyl compounds to be used to synthesize proteins. Used techniques such as IR, C-13 NMR, and H1-NMR to test for accuracy of compounds and for manual and machine purification. Gained experience with various types of laboratory equipment and an understanding of sterilization and safety techniques. Examples of experiments conducted include: • A kinetic study of the enzyme, Beta-galactosidase. The reaction rate of the enzyme using different substrate concentrations was the main focus. Data was collected using a spectrophotometer and a Michaelis-Menten plot. A Lineweaver-Burke plot was generated to determine the velocity and relationship of substrate. The velocity of the enzyme increased when the substrate concentration increased.• Microscale recrystallization of Acetanilide. The impure Acetanilide sample was put through hot gravity and vacuum filtration to remove impurities. An ethanol wash was used during vacuum filtration to theoretically yield promising results. The sample of Acetanilide was analyzed by testing the melting point. Compared to the literature value, the melting point of Acetanilide was a match, and the sample was purified.• The isolation of Beta-galactosidase from E.coli cells by using cell lysis, ammonium sulfate precipitation, and dialysis. After breaking up the bacteria cells, isolating the specific protein, and filtering unwanted impurities from the sample, the solution was tested using Coomassie and ONPG dye. The dyes were dropped into the sample and color change occurred. Beta-galactosidase was successfully extracted. Additional Experience:Server, 7/2019 to Present, Outback Restaurant, Turnersville, NJServer, 8/2013 to 6/2019, Don Pablos Restaurant, Deptford, NJ