Boston, Massachusetts, United States
Always passionate about new challenge, new opportunity.
• Lead late-stage Quality by design (QbD) process development, process performance qualification to determine and validate the control strategy. • Manage quality events including deviation, change control, CAPA to ensure satisfactory resolution and drug product quality. • Provide CMC inputs, as drug product SME to support late-stage registration and post approval changes. • Lead commercial continued process verification (CPV) using statistical tool to identify the opportunity for process improvements through lifecycle management. • Facilitate the RFP process and business review meeting with CMO.
Led formulation development and manufacturing processes, incorporating new technology manufacturing, packaging and distribution of clinical supplies. Contributed as a Technical lead in vendor selection and transfer technology to enable manufacturing of clinical trial supplies and preparation for product commercialization. Supported authoring of CMC sections for regulatory submissions
Technical Lead & Project Management • Lead cross-function R&D partners to drive business completion. • Perform product & process development, process scale-up of new global product. • Interface with global cross-functional organizations (Project Manager, Product Development, • Contract Manufacturing, Quality Control, Quality Assurance, etc) across internal and external to ensure continuity of project goal. Global E-commerce R&D team • To support global E-commerce R&D initiatives. • To lead and support Cross-Border activities.
Main Responsibilities as Senior Engineer at Salvona: Product and Process Development, Prototype, Technology Transfer, Scale-up and Validation. 1. Process Optimization Responsibilities includes Spray Drying/Congealing Process optimization(GEA Niro lab scale spray dryer, Tower spray dryer pilot scale) Mixing Process (high shear mixer, high pressure Homogenizer) Root Cause analysis, Out of trend analysis IQ/OQ/PQ for new equipment 2. Prototypes Responsibilities: In charge of all the prototypes from Benchtop to final commercialization. Experience in Flavor/Fragrance Nano-Encapsulation. Enhance Solubility for Hydrophobic, High Crystallinity Compounds Drug Delivery. Microencapsulation to increase active stability, prevent oxidation, etc 3. Management Responsibilities: Manage all the Engineers,Chemists and Operators to reach the company's goal in terms of production and product development project.
Worked under Good Manufacture Practice (GMP) to conduct experiments including method validation, dissolution testing, assays in the laboratory for the pharmaceutical industry. Method Development: Extraction Bio-assay Collected and analyzed experimental data via HPLC,LC-MS,GC