Tim Lee

Results-driven and innovative team leader with 15 plus years of biopharmaceutical experience. Proven track record in management of multi-disciplinary teams in product development and process transfer to manufacturing. Experience in achieving aggressive targets and timelines and productivity optimization. Analytical ability in providing insight from complex scientific data. Resourceful in achieving corporate goals through team leadership and crisis management.

Specialties: • Product development to launch (Bulk, Formulate, Fill, Pack)

• Strategic team leadership
• GMP clinical manufacturing
• Change management
• Process scale-up & validation by QbD
• Negotiation &communication skills
• Regulatory compliance
• Project management and 6-sigma
• Contract manufacturing
• Quality systems: SAP, Trackwise, LIMS, CAPA
• Process optimization (Fermentation, Protein recovery and Purification)
• Analytical methods: SDS-PAGE, HPLC, MS,UV-Vis, DSC, CD, AUC,