Development to Launch

- Directly supported process development of four portfolio molecules- Performed experimental design, kinetics studies, crystallization, distillation, extraction, active carbon purification- Supported a kilo-lab campaign to successfully scale-up clinical batches as the step engineer for 5 steps within four portfolios- Successfully scaled up processes from 10 g to 4 kg- Provide support, troubleshooting, and knowledge during tech transfer to a CMO facilities- Provide concise results and path forward based scientific approach and supported by experimental data- Preparation of Process Design Risk assessment- Reorganize the lab to meet current project needs with a safety first- Volunteered for a Departmental Safety Incident Investigator- Active member of laboratory monthly safety inspections- Optimized laboratory lab reactor lid to connect more PAT at the same time- Redesigned a purification breakthrough system to have an in-line PAT sensor to detect the actual breakthrough- Member of the Adsorption team for downstream purification support- Constructed a lab manifold to charge reagent into reaction stream to avoid safety issues if exposed to oxygen- Coach junior scientists on how to property setup experiment- Volunteered to support a new laboratory assembling for the synthesis of heterogenous catalyst and the catalytic performance evaluation. - Designing synthesis processes based on technical experience and safety aspects.

- Supported Pneumococcal polysaccharide vaccine conjugated vaccine commercialization process range finding.- Reviewed executed Electronic Lab record to support close-out documentation.- Optimized experimental templates used for experimental Electronic lab records.- Prepared a high-level schedule for a scale-down model confirmation campaign.- Supported archive searching for filling and develop a tool for easy tracking the findings for multiples serotypes.- Prepared a consumable and equipment layout for new laboratory using 5S methodology.- Provided feedback to improve our safety operational procedure and practices.- Trained new scientist on upstream and downstream experimental processes.

- Directly supported upstream and downstream activities-Provided recommendations during cell culture to maintain high protein yield- Supported fermentation activities: Seed reactor transfer into final bioreactor, temperature shift adjustments on bioreactor and cool down for protein harvesting- Provided support to centrifugation and protein capture steps- Depth filtration, ionic exchange capture chromatography resin packed column, delipid filtration, and viral inactivation- Provided scientific rational during resin chromatography column performance evaluation between batches purification steps- Monitored bioprocess PAT and attributes to assure the yield and product quality- Performed chromatography transitions analysis to determine actual HETP and elution symmetry- Provided technical evaluation as needed and support ongoing investigations- Designed, coordinated, and evaluated experimental data for an alternate cleaning agent- Provided technical support for the acquisition of new PAT during protein harvesting

- Directly supports process and equipment qualification activities for existing and new product launches- Prepares and reviews manufacturing protocols, Standard Operating Procedures (SOPs), Process Flow Diagrams (PFDs) and assessments for Annual Product Review reports (APR)- Project management: Leads and manages R&D projects for new products on the pipeline (5 products)- Coordinates campaign activities with multiples departments (QA Op, QA release, QA Compliance, QC, manufacturing, Engineering, logistics, R&D, etc.) for successful manufacturing activities- Prepares Change Controls for equipment and/or process qualification- Reviews and approves documentation as Master Formula Sheet batch tickets and Scale-up Protocols- Executes equipment’s readiness prior to manufacturing campaign- Supports and leads experimental, engineering and Scale-up lots- Supports Process Performance Qualifications, and review Instrument Operational Qualification (IOQ) and Performance Qualification (PQ) protocols- Transfers knowledge learned during engineering and exhibits lots to the process qualification NPI Team

Evaluated and improved in 15% manufacturing documentation for blending, granulation, compressing, compacting, coating, imprinting, and encapsulation Developed a manufacturing database for equipment and manufacturing documentation for 54 productsParticipated in various manufacturing projects in order to support the business need

Graduate Student• Outreach: Mentoring program to K-12 students and teachers.• Techniques: Oral presentation with interactive experiments for students motivation and teachersworkshops.

Graduate Student – PhD. Thesis project• Research: “Catalytic Conversion of Cellulose into Soluble Renewable Biorefinery Feedstocks”• To study the catalytic performance of bifuctional catalysts on hydrogenation of cellulose into sorbitol.• To study and improve the catalysts stability at reaction conditions on hot water.• Techniques: heterogeneous catalytic reaction on batch and continuous reactors, catalyst synthesis, SEM,XRD, TOC, GC-FID-MS, HPLC, FTIR, physical and chemical adsorption and solid acid characterization.

(Student)• Research: “Study changes in magnetic properties of Ni nanoparticles inside zeolites”• Techniques: Superconducting Quantum Interference Deviced (SQUID)

Prepare a rheology module of polymer gels for a new course.

• Worked on a cleaning confirmation protocol for a powder granulation equipment.• Worked on a Design of Experiment (DoE) followed by the preparation of experimental study protocol for a process optimization.• Working in the implementation of the experimental study protocol.

(Student)• Preparation of Pt electrode and AgCl electrode. “Study of the dissociation constant (K) of HCl and AceticAcid versus temperature and concentration of Propanol in water”.• Techniques: Basic chemistry techniques to measure solution’s voltage using electrodes.