Strategic Manufacturing Worldwide was founded by Scott M. Wheelwright, Ph.D. for the purpose of assisting companies in bringing products to market. With over 20 years experience in manufacturing and product development, Dr. Wheelwright has led many projects to successful completion. Dr. Wheelwright received his Ph.D. in chemical engineering from the University of California, Berkeley, his B.S. in chemical engineering from the University of Utah and completed post-doctoral studies at the Max Planck Institute for Biophysics in Frankfurt, Germany. Dr. Wheelwright has held leadership positions with Abbott Laboratories, Chiron, Scios, Calydon, DURECT and Genitope. Dr. Wheelwright is a member of the Editorial Advisory Board for BioProcess International magazine. Contact SMW at info@smwbiotech.com. Download Scott M. Wheelwright's Statement of Qualifications. Areas of Expertise Outsourcing and Manufacturing Operations Strategies for sourcing in-house or outside manufacturing, development, testing Minimizing costs defining project scope negotiating contracts managing projects Optimizing operations long range planning debottlenecking Preparation of Regulatory Documents chemistry, manufacturing and controls (CMC) sections Process Development downstream processing and purification fermentation and cell culture formulation, filling and drug delivery Facilities operation and compliance cGMP design and construction Product Development proteins and peptides therapeutics and vaccines diagnostics and devices With over 20 years in the biotech industry, Dr. Wheelwright has an long list of accomplishments. Led Outsourcing and Manufacturing Operations identified vendor, negotiated contract and managed scaleup to 3000 L for recombinant E. coli product with 2003 sales of over $300 million identified and negotiated multiple development contracts contracted-in and managed cGMP purification of inclusion body product to existing facility managed over 20 technology transfer projects, including to Europe and Japan Led Product Development prepared numerous IND, BLA and NDA documents for investigational and commercial products Led Process Development designed numerous purification, fermentation and cell culture processes for recombinant proteins Led Facilities Construction designed and supervised construction of 8,000 square foot cGMP aseptic manufacturing plant 10,000 square foot retrofit of cGMP fermentation and purification pilot plant 2,400 square foot cGMP cell culture pilot plant 20,000 square foot biotech laboratories Publications Baker, S. and S.M. Wheelwright, "Financially Based Modeling of Recovery Process Altrnatives," BioProcess International 2(5) (May 2004). Wheelwright, S.M. and S. Yamamoto, "Protein Purification: Process Design," Kagaku Kogaku 65(9):498:499 (2001). In Japanese. Wheelwright, S.M., "Economic and cost factors of bioprocess engineering," in Processing and Preservation of Biotechnological Products, K.E. Avis and V. Wu (eds.), Interpharm Press, Buffalo Grove, Illinois (1996). Wheelwright, S.M., "Commercializing Biotech Products," Bio/Technology 12:877-880 (1994). Wheelwright, S.M., Protein Purification: Design and Scale up of Downstream Processes, 228 pp, John Wiley & Sons, New York (1991). Now in third printing. Wheelwright, S.M., "The design of downstream processes for largescale protein purification, "Journal of Biotechnology 11:89-102 (1989). Burke, R.L., G. Van Nest, N.B. Gervase, C. Goldbeck, D. Dina, P. Brown, S. Wheelwright, and G. Ott, "Development of an HSV subunit vaccine: effect of adjuvant composition and antigen dose," in Vaccines for Sexually Transmitted Diseases, Butterworth Scientific, Ltd., Guildford, UK (1989). Wheelwright, S.M., "The impact of downstream recovery operations on upstream production methods: vertical integration and process optimization," in Biotechnology Research and Applications, J. Gavora et al. (eds.), Elsevier Applied Science, London (1988). Wheelwright, S.M., "Designing downstream processes for largescale protein purification," Bio/Technology 5:789-793 (1987). Wheelwright, S.M., J.M. Vislocky, and T. Vermeulen, "Adiabatic adsorption with condensation: prediction of column breakthrough behavior using the BET model," in Fundamentals of Adsorption A.L. Meyers and G. Belfort (eds), Engineering Foundation, New York (1984). Wheelwright, S.M., "Multivariant ion exchange: applications of weak-electrolyte resins," Ph.D. dissertation, Unversity of California, Berkeley (1982). Copyright © 2004 Strategic Manufacturing Worldwide