- Leading the system design activities between customer and GE for equipment hardware- Reviewing customer documents and understanding their process hardware requirements- Facilitating URSs review with customer and other stakeholders including manufacturing, automation, qualification, and product management- Generating third party GSs and coordinating customer reviews- Generating and maintaining detailed equipment hardware lists- Supporting consumables and bag design discussion- Supporting Manufacturing & QC for equipment set-up for FT/FAT, managing FAT deviation punch list, investigating and resolving design defects- Leading Product Risk Assessment and the Regulatory Checklist- Obtaining quotes and orders equipment from GE and third party vendors- Consolidating design inputs and URSs into GSs and resolving conflicting and ambiguous requirements- Ensuring all the hardware design deliverables are complete- Reviewing automation functional specifications and qualification protocols

Department of the Process Science, Protein Science, Develop and optimize purification processes for recombinant therapeutic antibodies,• Led purification process development and optimization for recombinant protein• Experimental design and execution at bench and pilot scales, resource planning.• Supported large scale operation at 12000L scale.• Participated in FMEA and gap analysis.• Coordinated tech transfer and NPI, provide planning BOM, process sizing for GMP runs, reviewed and approved GMP process description. • Coordination with other groups (MFG, SCM, QC, QA, EHS, E&T, Flextrain)• Authored GMP process description for Flextrain, consolidation run summary report.• Provided project updates in internal and external project team meetings.• Provided supervision and training to junior colleagues.• Responsible for call-out in the event of an emergency situation outside normal business hours related to the laboratories or related support facilities.• Proposed and facilitated continuous improvement projects.• Experienced in Lean Manufacturing, Six Sigma, 6S, Kanban, and Kaizen techniques.

• Developed and optimized purification processes for antibodies• Responsibilities include experimentation at bench scale as well as at pilot plant scale and supporting 2K liters scale,• Managed shipping and receiving logistics, RMs (chemicals, resins, consumables) planning for PD (2L and 100L, 500L).• Effectively communicate and shared observations with other groups. • Authoring, co-authoring and reviewing of reports and protocols as well as presenting project updates to the department or groups within and outside the department.• Responsible for call-out in the event of an emergency situation outside normal business hours related to the laboratories or related support facilities. Identify and propose improvements to existing control systems.• Led continuous improvement projects, lean manufacturing, Six Sigma, 6S, Kanban, and Kaizen techniques.

• Develop and optimize purification processes• Planned and executed bench and pilot scales experiments.• Routinely using the laboratory purification equipment such as AKTA, HPLC and TFF.• Drafted SOP's and Batch Production Records.• Shipping logistics and raw material ordering.

• Supported field trials for various customers: TFF, Mustang, Virus and DFF.• Performed field troubleshooting studies: Filter Failure analysis (in field advice & back to lab for failure analysis).• Resolved technical issues and recommended processing conditions. • Provided technical training to customers and supported critical meetings.• Integrity Tester Calibrations & IQ/OQ's (Certified) • Assistance in validation studies.

• Developed and optimized purification process (including chromatography, virus inactivation and UF/DF) for recombinant therapeutic protein production• Chromatographic process development included mix-mode, ion exchange, hydroxyapatite, hydrophobic interaction, size exclusion and affinity matrices).• Supported clinical trial material generation• Tech transfer from the lab to a cGMP pilot plant facility ensuring regulatory compliance.• Conducted periodic inspections of Laboratories and relevant support areas to ensure that established systems are implemented in an efficient and effective manner.• Monitored all the process equipment performance, work-practices and the physical infrastructure to keep laboratories fully functional.• Coordinated PM for purification laboratory equipment (and to understand and mitigate the effects of interruptions to the laboratories raw materials.• Built a collaborative relationship with the Laboratory Equipment Maintenance Team and provide coordinated activities with them.• Ensure that all Health, Safety and Environmental requirements are observed in relation to the work of the Protein Science group.Assistant / Associate Scientist, Pilot Plant• Participated in tech. transfer from process science lab to a cGMP pilot plant facility.• Prepared SOP's and Batch Production Records.• Performed polyacrylamide gel electrophoresis; western blotting; sterile technique; qualitative and quantitative assays for reaction products; LAL assay, preparation of GMP documents. • Provided technical support for equipment/process validation, including execution of ECO reports, IQs, OQs, PDs, and PPQs. • Assisted in drafting SOPs and Batch Production Records.• Trained and certified in the operation of scales, pH meters, spectrophotometer, conductivity meters, DCS system, chromatography column packing & skid, centrifuge, ultra-filters and clarification filters.• Responsible for training coworkers and maintaining training database.