Daniel Westrom Email & Phone Number

Denver, Colorado, United States

6278 S Troy Cir, Centennial, Co 80111

• Biomanufactured Humacyte’s human vascular graft (Humacyl®) product throughout phase 3 clinical trials following FDA 210/211 standards • Lead and troubleshot any technical and operational process deviations during the bioengineering process • Technical training and supervision of new technicians in Manufacturing Lab and Cell Expansion / Cell Culture clean rooms • Strong aseptic technique and adherence to cGMP, cGLP, and cGDP• Managed training plans and lab scheduling• Worked closely with product development scientists at Humacyte to continue development and process improvement through the clinical trial period• Developed a troubleshooting protocol for response to emergency alarms to prevent batch loss• Collaborated in identifying root cause of deviations and developing preventative action plans• Revised and implemented new standard operating procedures• Spearheaded implementing 5S into our laboratory to optimize layout. • Given “On-Call” responsibilities for batches in emergency situations. Responded to and independently resolved critical issues.• Presented updates on non-conformances and led weekly customer update meetings• Initiated, implemented, and closed change controls

8150 185Th St, Tinley Park, Il 60487

Cytogenetics Department – Cytogenetic Technician 9/29/2014-11/04/2016• Fluorescence in Situ Hybridization for diagnostic and pharmaceutical samples• Cytogenetic chromosomal analysis and testing• Assisted in the flow cytometry department • Operation and maintenance of all equipment within the cytogenetic department• Provided positive and effective interactions towards clients, co-workers, and vendors• Trained new cytogenetic technicians

Tinley Park

• Supported the successful delivery of clinical trial projects via operational day-to-day management of workflows.• Delivered excellent customer service to project stakeholders • Reviewed trial samples for discrepancies and clarified with the clinical sites • Managed clinical trial data entry • Trained new pharmaceutical accessioning employees and provide guidance • Assisted in company audits

616 Heathrow Dr, Lincolnshire, Il 60069

• Responsible for the analysis and review of laboratory data to ensure it complied with FDA regulations • Data analysis of Wet Chemistry, GC/HPLC, ICP and pharmaceutical compendia (USP, EP, and JP) procedures• Preparation and Review of protocols, method transfers, method validations, and SOPs• Collaborated with laboratory staff, scientist, and management in out of specification investigations to determine the root cause of discrepant data generated in the laboratory