Prakhar Gupta Email & Phone Number

• Proactively communicates clearly and concisely with stakeholders, teams, & contractors, with an understanding of each audience• Conducts project scoping for cross-functional, multi-dimensional, critical projects by being proactive and creative in order to achieve client's goals• Generates controlled documents including but not limited to design drawings, specifications, SOPs for start-ups, scale-ups, maintenance procedures, and any other operations, as needed, that reflect optimal project strategies• Lead, execute concurrently multiple capital projects involving different process equipment

Lead and execute in cross functional teams and manage large capacity of project workload simultaneously while providing quality service. Prioritize projects with minimal oversight and direction.• Adapt to support teams as needed to drive project outcomes (on time, on budget, meeting commitments and goals)• Ensure project schedules and plans remain up to date, highlighting activities on critical path and escalating issues to appropriate stakeholders as soon as they arise• Facilitate team communication and accountability

San Diego, California

• Lead engineer for clinical manufacturing suite; providing technical input for process equipment and manufacturing processes for commercial production of EXPAREL• Performed risk assessment, implemented preventative maintenance, troubleshot equipment and process issues and implemented process improvements• Provided strategies for new technology to improve efficiency and cost savings for the manufacturing plant• Executed and supported the development of new technology introduction of Tangential Flow Filtration platform by utilizing process analytics technology (PAT), Mettler Toledo Lasentec, allowing for COG reduction of approximately 20-30%• Provided support in areas such as data analysis identification of potential process bottlenecks and vulnerabilities, investigations into process abnormalities, and troubleshooting through the implementation of process overlays using critical parameters

Los Angeles, California

• Providing support through the engineering role for a brand-new startup building at Baxalta called the LAMP project• Projects involved design, specification, construction, and qualification of process equipment and process unit operations • Projects primarily consisted of capital projects not limited to: recovered plasma, vent line segregation, Filtration optimization• Provide technical support for the AHF-M NF process by assessing risks, implementing preventative maintenance, troubleshooting equipment and process issues• Hands on experience with activities which support process development and process characterization• Provide technical support upstream and downstream of the process for AHF-M NF and APD bulk process • Deliver technical support in the ramp up of Hemofil process by designing and executing process development studies to understand operating and performance parameters• Experience in chromatography columns and nanofiltration• Involved in the development and execution of test plans such as cycle development, Engineering protocols, final reports,IQ, OQ, and PQ validation for a variety of projects for the LAMP project

Baxter Bioscience

• Project requires working with process equipment, purified water systems (RO & WFI), process automation and general working knowledge of GMP and GDP• Test, run, and perform engineering studies on the COP equipment for multiple departments• Utilized PLC and DCS to create process designs for COP equipment• Increased working knowledge in Root Cause Analysis concepts• Responsible for managing WFI and RO to meet production needs • Involved in the development and execution of test plans, IQ, OQ, and PQ validation• Prepared design of experiments (DOE’s) for the critical system such as AWFI, RO, and CWFI production loops• Provided and managed LIMS data for all purified water systems (RO & WFI) and process air • Maintained spare parts data for the LAMP project using PIMS &JDE• Trained multiple departments in manufacturing in maintaining critical systems associated to their respective areas