Craig C.K. Lee, Ph.D.

109 Eagle Meadow Court Cary, NC 27519 (919) 775-7100 ext 6973 (Office) (919) 469-1034 (Home)

EXPERIENCE

Associate Director, Wyeth Pharmaceuticals, Biotech Division Sanford, North Carolina, August 2004 Present. Direct a team of Manager, Scientists and Engineers to provide validation services for equipment, cleaning, processes and automations for meeting regulatory compliance requirement. Identify validation gaps and develop legacy plans for meeting validation compliance. Closely work with Manufacturing, Engineering, QA, QC and Regulatory Affairs departments to ensure adequate schedule and functional support for successful validation activities. Develop validation project list to ensure adequate resources allocation and work with system owners to ensure validation activities are adequately prioritized. Work with other Wyeth facilities to determine best validation practices. Develop objectives for the validation team including setting goals and establishing professional developmental action plans with team members. Review and approve validation documents including protocols, reports, project validation plans, change controls and etc. Explain and defend validation results in front of inspection auditors. Provide technical inputs for the investigation of non-conformance events. Serve as SMEs for various equipment and unit operations in the Manufacturing area.

Project Manager, Bayer Corporation, Biotechnology, Berkeley, California, January 2003 July 2004. Supported $75 millions sterile filling facility (SFF) project by providing filling, freeze drying process equipment expertise to the project team with various functional responsibilities. Provided technical inputs to equipment design and testing requirement for freeze dryers, sterilizers, filling equipment, and other major equipment in the SFF project. Managed projects for steam sterilizer, clean steam generator and parts washer to ensure meeting equipment specs, purchasing requirement, project schedule and budget. Actively involved in the risk analysis and impact assessment for SFF project to ensure potential failure has been accounted for prior to equipment purchase. Reviewed and/or approved user requirement, equipment specs, software design description, validation master plan and commissioning protocols. Actively involved in SFF project equipment commissioning/qualification activities including FAT, SAT and equipment/facility qualifications.

Engineering Manager, Bayer Corporation, Biotechnology, Berkeley, California, July 1999 December 2002. Lead a team of plant/PCS engineers to ensure reliable operations in parenteral filling, freeze drying and protein purification, for the manufacturing of recombinant and plasma derived protein products. Provided technical supports to various production unit operations including chromatography purification, pasteurization, sterile bulking, filling, freeze drying, steam sterilization, dry heat sterilization, vial rinsing, over-seal capping, WFI storage/distribution, clean room facility and etc. Supervised engineering activities including preventative maintenance, troubleshooting, facility shutdown and continuous improvement for the manufacturing equipment and facilities. Lead PQ for WFI storage & distribution system; reviewed and approved IQ, OQ, PQ & Re-qualification protocols/reports for plasma purification, filling, freeze drying equipment & facilities. Resolved manufacturing/process discrepancies through root cause analysis and provided adequate corrective actions. Engineering Supervisor, Bayer Corporation, Biotechnology, Berkeley, California, October 1996 - July 1999. Actively involved in the retrospective qualification for the equipment and process/cleaning process used in the plasma purification operations. Provided technical supports for sterile bulking and purification operation including chromatography column purification, ultra-filtration, pasteurization, steam sterilization and sterile bulking for the manufacturing of protein products in the GMP facility. Supervised a team of technical trainers for training production personnel on manufacturing processes. Coordinated and resolved compliance issues with QA and RA for conducting clinical production project using the existing licensed facility. Investigated root causes for product/equipment/facility non-conformance or failures, and provided corrective actions. Conducted continuous improvement (CIP) project by increasing production yield while maintaining product quality. Production Specialist, Miles Inc./Bayer Corp., Bushy Park Plant, South Carolina, June 1993 - October 1996. Worked on special projects to resolve quality issues in dyes & organic pigment manufacturing. Analyzed organic pigment manufacturing data to identify critical process parameters. Developed alternative technologies and modified operating procedures to improve product quality and production consistency; Mapped production process and evaluated process cycle time & capacity utilization for production de-bottlenecking. Lead a re-engineering sub-team to identify and implement improving opportunities for organic pigments manufacturing process.

General Supervisor, Miles Inc./Bayer Corp., Bushy Park Plant, South Carolina, June 1992 - June 1993. Supervised cross flow membrane filtration technology development including ultra- and micro-filtration for dyestuff applications. Supervised pilot plant operation and provided training on operations of Fisher UNIVOX distributed control system. Senior Chemical Engineer, Mobay Corporation/Bayer, Bushy Park Plant, South Carolina, December 1989 - June 1992. Worked on process design and P&I development for building a $4 million organic pigment pilot plant project. Configured Fisher UNIVOX automation system for the pilot plant process control. Started up and commissioning pilot plant including instrument loop check & tuning, and water/solvent batching. Scaled up and transferred various organic pigment processes from pilot to production scale. Senior Scientist, Recra Environmental, Inc., Amherst New York, March 1987 - December 1989. Supervised bench and pilot scale experimental investigations. Conducted and managed waste treatability studies. Provided environmental consulting services. Postdoctoral Research Associate, Department of Chemical Engineering, Syracuse University, February 1986 - March 1987 Supervised and conducted various research projects. Wrote technical proposals and reports. Presented research results at technical conferences. Explored new ideas for research proposals.

EDUCATION

Ph.D., Chemical Engineering, Syracuse University, May 1986. B.S., Chemical Engineering, National Central University, Taiwan, July 1976.
1999 Bayer Presidential Achievement Award top ten team 1999 Bayer Quality Excellence Award 2001 Bayer Special Recognition Award 2002 Bayer Quality Excellence Award Co-author of 11 publications and 9 presentations Member of PDA Available upon request

AWARDS

PUBLICATIONS MEMBERSHIP REFERENCES