Harvey Li Email & Phone Number

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Responsible for tech transfer, support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturingProvides technical and lab-based support for clinical and commercial manufacturing. Leading and/or supporting process investigations, raw material changes, consumable changes and process improvements which increase operational efficiency in manufacturing in order to improve capacity to deliver life-saving therapies to patients. Major Accountabilities:• Design and execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment.• Analyze experimental data and aid in analysis to draw conclusions.• Participate in Root Cause Analyses to determine cause of manufacturing process investigations.• Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data. • Support production related investigations, ensuring compliance with internal standards and regulatory requirements.• Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.• Execute process comparability and process validation studies including planning and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes.

Lawrence Township, Nj, Us

Basel, Baselstadt, Ch

Manufactured Kymriah, Novartis' CAR-T cell therapy.Major Accountabilities:• Ownership for the processing of the assigned patient starting material in the clean room environment• Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time• Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax• Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in-process environmental monitoring• Maintains and prepares equipment/environment for use• Proficient in the use of production related IT systems such as SAP, LIMS and MES• Documents all steps in the assigned batch record in line with GMP requirements• Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique• Conduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique• Assist on Deviation Investigations and Inspections• Participation in assigned qualification/ validation activities• Responsible for successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role• Maintains an “audit ready” module

Mediated conflicts that arose in the residence halls, enforced hall policies, and encouraged residents to realize their fullest potential at Penn State through the use of strong verbal and written communication skills

Studied how cell morphology affects nanoparticle uptake as well as how the leading edge of a cell compares to the trailing edge for nanoparticle uptake• Cultured MC3T3 cells• Created coverslips coated with PMMA to create a biocompatible surface suitable for cell growth• Utilized immunostaining, fluorescent polystyrene nanoparticles, and fluorescent microscopy to observe cellular intake of nanoparticles• Performed microcontact printing to influence cell morphologyConducted a project examining chondrogenesis on nanofibers of varying diameters• Cultured mouse mesenchymal stem cells (MMSCs)• Electrospun poly-L lactic acid (PLLA) nanofibers of varying diameters onto pHEMA coated cover slips• Plated MMSCs onto the cover slips and cultured them in chondrogenic media• Used Alcian Blue to stain the glucosaminoglycans (GAGs) within the cells and imaged them on a microscope

Master Of Public Health - Mph, Biostatistics

Master’S Degree, Biomedical/Medical Engineering

Education record

Engineering Design