Kevin Wong

-Manage all upstream/cell culture operations of Phase 1 Biologics for Clinical Trials. -Write and execute validation protocols for new equipment. -Works closely with Process Development for Technology Transfers of new products and processes. -Write/Review GMP documentation (Batch Records, Forms, SOPs, Work Instructions). -Create and Engineer connections to bridge existing equipment and new processes/equipment.

• Supervises all aspects of respective areas of operations. (Team of 5-10) • Manage multiple complex capital funding projects • Managed projects for the implementation of new technologies • Developed connections with new companies to solve existing productivity issues • Point person for BioPhorum disposable technology industry alignment initiative (developed strong intercompany relations) • Schedules tasks to ensure projects and company demands were met on time. • Runs and participates in deviation root cause analysis and CAPA generations • Point of contact for regulatory audits as SME and management • Performance management and budget management through salary increases. • Hiring and interviewing candidates for entry and senior manufacturing positions

• Supervises all aspects of respective areas of operations. (Team of 10-15) • Reviews and edits batch records in accordance with cGMP standards. • Schedules shift duties and batch tasks based on master production schedule. • Performs cGMP audits of production area. • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations. • Perform Area management review of Change Controls, Corrective or Preventative Actions (CAPA), Evaluation of Event (EOE), Notice of Event (NOE),Deviation Notification Form (DNF)

• Lead day to day operations for upstream processing (Team of 4-5) • Reviews and edits batch records in accordance with cGMP standards. • Ensured equipment readiness and coordinates regular equipment maintenance and calibrations; troubleshoots equipment. • Manage new equipment start up and cross department projects • Lead and managed Technology transfer teams for multiple molecules from Pre-clinical manufacturing and process development to Clinical Scale Manufacturing

• Lead day to day operations for upstream processing (Team of 4-5) • Project management (clinical scale molecule campaign) • Lead Process area start up and validation of brand new fully single use processing suite • Perform investigations for Evaluation of Event (EOE), Notice of Event (NOE),Deviation Notification Form (DNF)

Supervisors: Dr Scott Seidman, Dr. Amy Lerner Faculty Advisor: Dr. Dean Johnson Airbrasion Wound Debridement System: Developed and tested a unique wound debridement system which will be a small portable first line of defense that can be used in emergency situations.

• Conducted research on second harmonic generation in breast cancer tumors. • Used a Two-photon microscope to image invasive ductal carcinoma samples and analyzed the images to obtain forward/backward ratios in order to compare tumor grades to metastasis of the tumor. • Learned and applied histological techniques such as fixation, embedding, sectioning and staining. • Programed a search application (using MATLAB) that complied tumor data that greatly reduced the amount of time needed to find specific tumor information.

• Conducted research on mechanosignaling on vascular endothelial cells. • Researched the possible phosphorylation of PECAM-1 by mechanical forces such as fluid flow and stretch. • Engineered new silicone test chambers for the laboratory, eliminating need for previous expensive test chambers • New polydimethylsiloxane (PMDS) test chambers was significantly cheaper than existing test chamber, decreased amount of proteins used to run tests and allowed for more uniform test results • Assisted in possible new methods paper on active-protein attachment to silicone membranes. • Bio engineered proteins to have specific fluorescent tags.