Kevin Lu

Biography

Business Development Manager Company NamePhyton Biotech Dates EmployedMay 2017 – Present  Employment Duration8 mos LocationVancouver, Canada Area  Phyton Biotech Associate Account / Project Manager (Business Development & Project Management) Company NamePhyton Biotech Dates EmployedMar 2016 – Apr 2017  Employment Duration1 yr 2 mos LocationVancouver, Canada Area  Phyton Biotech Quality Control Supervisor Company NamePhyton Biotech Dates EmployedAug 2012 – Mar 2016  Employment Duration3 yrs 8 mos LocationVancouver, Canada Area Manage the operation of Quality Control laboratory under strict cGMP. Lead / manage method development; method validation; instrument qualification; investigation; troubleshooting; stability programs; etc activities in QC. Manage Empower data system, including installation, system validation and employee trainings. Prepare and participate in all major regulatory submissions for finished APIs and major customer / regulatory agency (FDA, EDQM, Health Canada, Australian TGA, Koran FDA, Japanese FDA, etc) audits. Generate and approve GMP document, including SOPs, CAPAs, Change Controls, protocols and Certificate of Analysis, etc.    Phyton Biotech Sr. Scientist, Quality Control Company NamePhyton Biotech Dates EmployedJun 2011 – Aug 2012  Employment Duration1 yr 3 mos LocationVancouver, Canada Area Lead and perform method development and validation. Design, setup and validate calculation templates for analytical test methods. Perform instrument maintenance and troubleshooting, including KF titrators, HPLC, GC, etc. Manage Empower data system. Generate and review GMP documents. Provide technical support to customers and R&D group.    Phyton Biotech QC Scientist Company NamePhyton Biotech Dates EmployedOct 2009 – May 2011  Employment Duration1 yr 8 mos LocationVancouver, Canada Area Perform routine analysis for raw materials, in-process samples and finished products. Participate in method development, validation, GMP documents writing and review. Maintain reference standard inventory, stability programs and instrument qualification schedules. Perform instrument troubleshooting and repairs. Train new employees.    Natural Pharma Canada Senior Quality Control Specialist Company NameNatural Pharma Canada Dates Employed2007 – 2009  Employment Duration2 yrs LocationVancouver, Canada Area Participate in technical transfer projects / studies within NPI companies. Train new employees. Perform instrument installation, maintenance, repairs and qualification. In charge of implementation of compendial methods according to USP and EP. Generate and review GMP documents. Provide technical support to manufacturing and R&D groups.    Syntax Biotechnology Ltd Production Chemist Company NameSyntax Biotechnology Ltd Dates EmployedJul 2005 – Jan 2007  Employment Duration1 yr 7 mos LocationShanghai, China Manufacture APIs under GMP. Perform organic chemistry synthesis, purification, precipitation, columns, fraction collection, drying and packaging. Perform in-process testing and online quality control within manufacturing group. Participate in R&D-to-commercial batch conversion, batch scale-up and process validation. Also involved in equipment design, setup and qualification.    Syntax Biotechnology Ltd Assistant Engineer Company NameSyntax Biotechnology Ltd Dates EmployedJan 2005 – Jan 2006  Employment Duration1 yr 1 mo LocationShanghai City, China Worked as an engineer and AutoCAD designer under a register professional engineer in the USA. Work includes engineering related calculations, AutoCAD drawings and reviewing for plant utilities, P&IDs, piping, cleanroom HVAC airflow diagrams and ductwork layout for pharmaceutical facility.

Research Interest

Neurology, Neuroscience, Neurosurgery, Bipolar disorder, Stroke