Kevin Wu Email & Phone Number

Port Washington, New York, Us

-Spearhead the management of the Pall R&D project portfolio, overseeing project roadmaps, resource allocation, and escalations to ensure alignment with organizational goals and strategic initiatives.-Facilitates monthly "Technology Planning Group" meetings with leadership teams to drive strategic decision-making and prioritize initiatives within the R&D project portfolio, ensuring alignment with organizational goals and maximizing resource utilization for optimal outcomes.-Oversee the Agile software development project, coordinating sprint planning, managing timelines, and tracking deliverables to ensure adherence to scope, budget, and deadlines.

Brea, California, Us

Engineering role focused on introducing/sustaining productivity increasing and cost reducing initiatives within a fast paced manufacturing environment-Led capital acquisition projects through design, URS creation, contract partner evaluation, and Commissioning & Qualification.-Spearheaded $800,000 in annual cost savings by leading cross functional teams of up to 10 members to optimize operations efficiency.-Managed timelines and budgets for multiple projects using PMP tools, resulting in on-time and under-budget project completion.-Facilitated several multi-day Kaizen events utilizing Lean Six Sigma tools: 3P, VPM, VPI, VSM, & VPI.-Acting site lead for Asian Descent + Friends Associate Resource Group, planning multiple cultural events.

Rahway, New Jersey, Us

-Rotated through business critical Merck manufacturing roles as a flexible contributor/leader to drive results-Took on challenging developmental roles in supply chain, operations, and quality assurance while mentored by executives and performance leaders in their respective roles.-Extensively trained in standard manufacturing practices including Six Sigma, Lean Manufacturing, Eight Step Problem Solving, A3 Thinking, Hoshin Kanri, Kaizen, Kanban, and more.-Led a multi-disciplinary team in implementing a dynamic production scheduling tool to achieve a site goal of increasing batch output by 57%. -Created a comprehensive product launch strategy for the highly successful pharmaceutical drug "Keytruda," aiming for significant market penetration and revenue growth.-Managed domestic and international risks associated with the launch and distribution of "Keytruda," ensuring compliance with regulatory requirements, & mitigating potential liabilities.

-Formulated scaffold synthesis methods including cryogelation, gas foaming, and salt leaching, based on reviewed published literature-Examined mechanisms of monocyte recruitment and differentiation within methacrylate-hyaluronic acid scaffolds and methacrylate-alginate scaffolds - Synthesized methacrylate-alginate scaffolds with varying levels of sodium bicarbonate and acidic buffer to observe changes in pore sizes-Presented research findings at the Stanford Undergraduate Research Conference, Harvard Conference for Undergraduate Research, National Conference for Undergraduate Research, and the J&J Engineering Showcase

Rahway, New Jersey, Us

- Led a team of engineers in the design review, purchase, and installation of pipe to drum fittings for waste solvent disposal in a hazardous classified environment- Created automated data collection tools for vision inspection process analytics utilizing Pipeline Pilot software- Created visually appealing and informative electronic dashboards for manufacturing operations equipped with analytical graphs, process control limit alarms, and statistics specific to each machine center- Assisted in facilitating vendor relations, design, and installation for a new filling & inspection manufacturing line at MSD Carlow, Ireland- Created over 200 uniquely defected product samples for the development of effective vision inspection recipes- Trained in vision inspection industry standards, including principles of manual baseline standards & environmental controls for accurate measurements.

New Brunswick, Nj, Us

-Justified a reduction in product fill weights utilizing Minitab analytics, creating over $70,000 in cost savings annually-Assisted in the implementation and validation of a new packaging line, capable of supporting 400,000 units per year-Designed, purchased, and installed communication boards to facilitate information flow on the most productive packaging lines-Utilized Excel analytical tools to track over 15 in depth waste and efficiency metrics including bulk production speed and profitability

Telford, Pa, Us

-Created GAMP5 compliant User Requirement Specifications (URS) for direct impact software forms and templates.-Authored and executed software validation protocols for direct impact software, templates and forms to ensure compliance to revised ISO 13485: 2016. -Authored and executed ISO 13485/GMP 820 compliant IOQ protocols for various process equipment utilized for medical component manufacturing (biomaterial, textile and woven/braided structures).-Authored and obtained approval for medical component process and support equipment work instructions and SOPs.-Validated internal ERP system, Microsoft Dynamics AX, saving Secant Group $30-40k in third party validation costs-Monitored qualified DI Water system via water sample collection for bioburden, endotoxin, and TOC level measurement. Performed analytical water sample endotoxin testing utilizing gel clot method.-Monitored product contact air and nitrogen systems

Philadelphia, Pennsylvania, Us

-2017 Stanford Undergraduate Research Conference-2017 Johnson & Johnson Engineering Showcase-2017 National Conference for Undergraduate Research-2017 Harvard Conference for Undergraduate Research-2017 Drexel STAR Summer Showcase

Philadelphia, Pennsylvania, Us

-Examined mechanisms of monocyte recruitment and differentiation within methacrylate-hyaluronic acid scaffolds and methacrylate-alginate scaffolds-Trained in several essential wet laboratory procedures including microscopy, micro-pippetting, cell cultures, ElISA and flow cytometry-Completed all tasks while strictly adhering to lab safety procedures-Attended weekly lab group meetings to discuss research progress in a professional setting-Created and presented a research poster at a Drexel Undergraduate research conference attended by judges, professors, and industry professionals

-Prepared account statements to be presented to clients, processed in Excel and ACT Systems-Received and dispatched calls in an office of 10+ employees-Coordinated client events for 50+ attendees-Greeted and assisted customers at the reception desk-Represented the company at sponsored social events-Attended meetings with both clients and market advisors

Master’S Degree, Summa Cum Laude, Materials Science And Engineering

High School