Nicholas Fedorko Email & Phone Number

El Segundo, California, United States

El Segundo, California

Frequently completed investigations from beginning to end, including: Identification of incident, determination of solution, execution of solution, and verification of effectiveness. (Root Cause Analysis, Impact Assessments, Change Controls)Led teams to identify possible MFG process improvements. Authored technical documents to support new decisions and processes via statistical analysis. Successfully implemented MFG changes with cumulative net waste reduction of $15MM+… Show more Frequently completed investigations from beginning to end, including: Identification of incident, determination of solution, execution of solution, and verification of effectiveness. (Root Cause Analysis, Impact Assessments, Change Controls)Led teams to identify possible MFG process improvements. Authored technical documents to support new decisions and processes via statistical analysis. Successfully implemented MFG changes with cumulative net waste reduction of $15MM+ annually. Supported MFG Floor operations through generation of emergency protocols during deviation events.Provided bimonthly process training (Overview of "why" the process is effective) for new hires as well as various departments upon request. Show less

Tustin, California

Providing excellent biologics manufacturing expertise to reliably generate quality products for clients. • Perform daily monitoring of equipment• Operate and maintain cell culture bioreactors (100L – 1000L stainless steel and disposable STR/SUB) in • batch, and fed-batch• Perform equipment cleaning and sterilization – manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP)• Responsible for cell culture expansions and aseptic techniques (thaw… Show more Providing excellent biologics manufacturing expertise to reliably generate quality products for clients. • Perform daily monitoring of equipment• Operate and maintain cell culture bioreactors (100L – 1000L stainless steel and disposable STR/SUB) in • batch, and fed-batch• Perform equipment cleaning and sterilization – manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP)• Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a BSC)• Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, and CIP skid• Harvest operations - pod filtration and TFF system• Operate Sartocheck filter integrity testers• cGMP Documentation• Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms• Maintain cleanroom facility and equipment• Assist with MQS investigation of manufacturing incidents. Show less