Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 76-78). / Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that was defined in the International Conference on Harmonization (ICH) Q8 guideline in 2005. Expectations are that QbD will ultimately become a regulatory expectation and prerequisite for drug approval. The pharmaceutical industry has made significant progress in applying QbD principles for small molecules, and efforts to adapt the new paradigm to biologic products are gaining momentum. Although the primary motivation for adopting QbD is regulatory expectation, the business impact of QbD has not yet been defined. The purpose of the business case is to examine the internal impact of QbD using Amgen, Inc. as a model large biopharmaceutical company. This assessment aims to identify the most critical areas of focus and to align expectations around the impact of QbD. The business case captures the impact of QbD throughout the commercialization process, from drug discovery to commercial production, by applying a conceptual framework that divides the commercialization process into four major elements: Molecule Selection, Process Development, Technology Transfer, and Marketing Application & Commercial Production. Examples of on-going activities were identified within each of these elements to estimate the economic and operational impact of QbD. One of these examples was based on a deep-dive technical analysis of Smart Freeze Dryer technology, a novel means of lyophilization cycle development and temperature control. / (cont.) The business case demonstrated that internal drivers do exist for the systematic implementation of QbD. Up-front investment early in the product life cycle offers economic and operational benefits later in development and commercial production. In addition, organizational learning and process development evolution lead to cumulative benefits for subsequent pipeline products. Though the magnitude and timing of investment depends on the available resources and long-term strategy of the business, investment should be concentrated in three key areas: Science & Technology, Knowledge Management Systems, and Business Processes. / by Julie Matthew. / S.M. / M.B.A.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 50-51). / In 2007, Dell made the decision to make another attempt at selling computers through the retail channel in an effort to stimulate growth. Dell has been extremely successful in the direct channel and they are now trying to adapt their capabilities and their supply chain so they can meet the challenges and requirements of the new distribution channel. Retailers require large orders on specific dates, they want multiple configurations available to them, they want the most competitive prices, and they want to delay purchase commitments as long as possible. Before 2007, Dell had been manufacturing their notebooks in Dell-owned facilities in Asia. They would then fly the notebooks to the Dell merge center in Nashville, TN before shipping them to the retailer distribution centers. Dell has now begun outsourcing much of the notebook manufacturing to manufacturing partners, or contract manufacturers, in Asia and is continuing to look for other ways to cut costs. One opportunity for significant savings is to switch the method of product transportation from air shipment to ocean shipment. There are a number of issues associated with this option so the change needs to be done correctly or all of the savings could be lost due to other costs such as expedites, excess and obsolescent inventory, and retailer penalties. The difference in lead-time between air and ocean shipment is significant. To evaluate the positive and negative effects of an ocean shipment strategy at Dell I explored two specific cases. The first case analyzed involved notebook orders to Dell's largest customer in the retail channel. / (cont.) The main concern regarding ocean shipment in the retail channel is the risk of order cancellation while the finished product is on the water. Therefore, the approach I used was to determine a break-even point and what the cancellation risk would have to be for the costs and benefits to cancel each other out. The second case analyzed involved orders to one of Dell's largest commercial customers. This customer was selected because they typically order a standard configuration and because a finished goods inventory is already maintained by a third party to fulfill their orders. This case allowed me to determine how much additional inventory would have to be maintained due to the increase in lead time. These two scenarios cover a variety of products and channel issues, and have applicable lessons to other customers. / by Adam Nelson. / S.M. / M.B.A.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 86-87). / Since the signing of NAFTA in 1993, North American automotive OEMs have moved final assembly and other manufacturing operations from domestic locations to international locations. Mexico provides a relatively inexpensive labor force and is within geographic proximity of the US. Tier One suppliers have also relocated some operations to Mexico, such as American Axle & Manufacturing (AAM) and its Guanajuato Gear & Axle (GGA) facility, where this study was performed. While the proportion of GGA's inbound material sourced in Mexico has increased, this still represents a small fraction of GGA's supply base. Numerous efforts have been made at localization of suppliers to Mexico, both through existing suppliers relocating and the development of Mexico-based suppliers. For the suppliers remaining in the US and Canada, there are numerous possible transportation solutions, including FTL, stacktrain, LTL, and milkruns. The crux of this thesis lies in the hypothesis that GGA would be better able to optimize logistics, if it had the ability to choose mode and frequency on a real time basis after having a more precise understanding of inbound material flow. A case study was then performed on the optimal manner in which to ship empty returnable containers to suppliers, which is established to be per container demand at the supplier site. Then, a model is developed and tested that takes as input the forecast of raw material shipments from GGA's entire supply base and outputs a set of packing lists that minimizes logistics cost while meeting supplier demand for empty containers. / (cont.) The model outputs are tested on a limited basis, but full implementation has not been conducted at the time of writing. Based on preliminary calculations, it is expected that implementation would have a significant impact on GGA logistics expense. / by Peter Frys. / S.M. / M.B.A.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Cataloged from PDF version of thesis. / Includes bibliographical references (p. 85-88). / Aerospace firms continue to outsource increasingly complex components and systems for access to talent, lower costs, and global presence. In addition to strong competition from Airbus and other emergent companies, Boeing is faced with the challenge of reducing financial risk and placing work internationally to offset foreign sales obligations. The organization has recognized a need for an integrated framework to consistently make sourcing decisions that limits subjectivity and positions the company for continued success. This thesis is based on a six-month internship study with the Future Production System team based in Seattle, WA and it examines the strategic sourcing decision process at Boeing Commercial Airplanes. A discussion-based strategic sourcing process utilizing a holistic range of factors is proposed to test whether an expensive, complex, and integrated system like a composite airplane wing should be outsourced or if it should be designed and produced internally. This workshop-based strategy development process develops weighted factors through a structured, cross-functional process where multiple proposals can be evaluated based on their performance against a set of quantitative and qualitative factors such as cost, quality, flow, knowledge management, stability, and risk. The development of a baseline sourcing proposal for a composite airplane wing demonstrated the process. Careful assumptions were made and data collected to ensure a realistic scenario for a future single-aisle plane. The documented baseline wing sourcing strategy includes recommendations for proximity, design integration, and production responsibilities. / by David T. Hsu. / S.M. / M.B.A.

Thesis (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; and, (S.M.)--Massachusetts Institute of Technology, Sloan School of Management; in conjunction with the Leaders for Manufacturing Program at MIT, 2003. / Includes bibliographical references (leaf 95). / by Sheila J. Bragg. / S.M.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 1999. / Includes bibliographical references (p. 48). / by Christopher Chan Ogden, II. / S.M. / M.B.A.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 1999. / Includes bibliographical references (p. 65-66). / by Alison Dale McCaffree. / S.M. / M.B.A.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2002. / This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections. / Includes bibliographical references (p. 81-82). / by Timothy J. Sweitzer. / S.M. / M.B.A.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Civil and Environmental Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2003. / Includes bibliographical references (p. 85-87). / by Thomas L. Threadgold. / S.M. / M.B.A.

Thesis (S.M.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Civil and Environmental Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2003. / Includes bibliographical references (p. 77-78). / by Kristin Elisabeth Toth. / S.M.