Manufacturing Consultants: 9

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. 

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. 

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Consulting Services: 

View Timothy Anderson's Expert Witness Profile.

The four PhD and registered PEs at Miller Engineering are celebrating 40 years of Professorships at three universities along with providing services to Government, Insurance, and Industry—through research, publications, presentations, and expert testimony. We have a dedicated office with a full time staff of engineers, researchers, and technical writers. The span of our collective academic and experiential expertise covers well the Mechanical, Electrical, Chemical, Agricultural, Industrial, Human Factors, Ergonomic and Safety fields of engineering. The areas listed below are from actual projects completed in our 40 years of history. 

Summary

Stephen (Steve) T. Hopper, PE, is Founder and Principal of Inviscid Consulting. Over more than three decades, Steve has helped hundreds of clients plan and streamline their warehousing, logistics, manufacturing, and distribution operations by driving down operating costs, boosting capacity, improving service levels, mitigating risk, implementing effective supply chain solutions, emphasizing safety, and enhancing the performance of their supply chain resources: people, processes, inventory, facilities, equipment, material handling systems, transportation assets, and supply chain information technology (IT). He has worked with clients ranging from small businesses to Fortune 100 corporations.

Steve earned a Bachelor of Industrial Engineering (BIE) degree from The Georgia Institute of Technology (Georgia Tech) and is a board-certified, licensed, registered Professional Engineer (PE). He has served as an expert witness on dozens of cases involving supply chain operations in the US, Canada, and Australia and has advised private equity and venture capital investors. He has also been interviewed by the supply chain industry media, authored articles for industry publications, and spoken at industry events.

Industry Experience

• 3PL / Outsourced distribution and fulfillment
• Apparel / Footwear
• Building materials
• Consumer goods
• Direct-to-consumer / Ecommerce / Catalog
• Food / Beverage / Grocery
• Furniture
• High-tech / Electronics
• Industrial / Automotive / Aerospace
• Mining / Drilling
• Pharmaceutical / Health and life sciences
• Rentals
• Retail
• Reverse logistics / Returns
• Wholesale / General distribution

Supply Chain Solutions Expertise

• Warehouse management systems (WMS)
• Warehouse control systems (WCS)
• Warehouse execution systems (WES)
• Slotting and order picking systems
• Transportation management systems (TMS)
• Labor management systems (LMS) 
• Order management systems (OMS)
• Voice and automatic identification systems
• Equipment, automation, robotics, and software used for handling, packaging, storing, and transporting materials
• Logistics network design & optimization software tools

Education, Certifications, and Associations

• Bachelor of Industrial Engineering (BIE), The Georgia Institute of Technology (Georgia Tech)
• Board-certified, licensed, registered Professional Engineer (PE)

Finity Engineering, LLC comprises highly-accomplished engineers and industrial practitioners that work alongside leading researchers to provide design, analysis, consulting, and litigation support services. Associates are subject-matter experts in the areas of Automation, Mechatronics, Robotics, and Consumer Products.

Finity Engineering professionals have served scores of industry-leading companies and research institutes, and have developed and provided technical oversight for the implementation of hundreds of robotic, automation, and controls systems deployed within the facilities of high-profile end users. Collectively, Finity Engineering professionals are named inventors on over 60 patents and have founded dozens of successful entrepreneurial ventures, demonstrating pragmatic and marketable engineering innovation.

Clients Include: Alcoa, Apple, BMW, Boeing, Cargill, Caterpillar, Chernobyl, Cummins, Ford Motors, Fukushima, General Motors, Gestamp, Google, Honda, Hundai, Jet Propulsion Laboratory, Johnson Controls, Kia Motors, Lockheed Martin, and many more.

Design, Analysis & Business Consulting Specialties:

 Founder, Khalid Sorensen, PhD, is a highly accomplished technology leader in Automation, Mechatronics, Motion Control, Manufacturing, Machine Vision, and Human-Machine Interaction. He has over 20 years of experience developing and deploying world class, mechatronic, motion control, and automation solutions.

Dr. Sorensen has directed the development and implementation of 100s of complex, multi-disciplinary mechatronic systems for high-profile industry leaders including Toyota, Ford, Alcoa, Caterpillar, Boeing, NuScale, and many others, and high-profile facilities including Fukushima and Chernobyl.

Previously, Dr. Sorensen Founded a technology company where he invented and was the Chief Architect of Expertoperator^TM, Safemove^TM, Automove^TM, and Cranevision^TM – technology known within the primary metals, automotive, and heavy-equipment sectors for enhancing crane safety, productivity, and ease-of-use; Developed state-of-the-art, on-line, time-optimal trajectory synthesis software for Cartesian machines - key drivers in the acquisition of his company 5 years after inception by a global leader in automation.

View Dr. Khalid Sorensen's Expert Witness Profile.

JOHN A. WILLIAMS, PhD, PE, ASA, MBA, CFEI, AIChE Fellow

Dr. Williams is an International Engineering and Energy Technology Expert in the engineering analysis and financial appraisals of energy, power, and manufacturing technologies, related intellectual property (patents, trade secrets, trademarks), licensing, royalty structures, market analysis, infringement, contract breach, fraud, compensatory, taxation, and lost profit damages. Dr. Williams provides engineering analysis, forensics, financial appraisals, and quantification of economic damages for oil & gas production, solar, wind, manufacturing, oil refining, chemicals, power generation, electrical distribution, steam, RNG biogas, biomass, ethanol, biodiesel, bioprocessing, food ingredients, geothermal, coal, nuclear, steelmaking, glassmaking, storage, pipelines, water treatment, and waste-to-energy technologies, equipment, construction, and facilities.

With over 40 years of industry experience in operations, R&D, cost estimating, finance, and construction (EPC, EPCM), Dr. Williams offers a unique synergy of engineering expertise and business acumen. His exceptional ability to analyze complex technical and financial matters and express them in understandable terms has made him a sought-after expert witness in litigation risk and exposure, dispute resolution and high-stakes litigation.

Dr. Williams has led EPS, a full-service engineering firm, since 1995. Since 1996, he has been recognized by AIChE, ASME, and ASA for developing and instructing courses in technology development, project management, cost engineering, financial evaluation methods, and financial appraisals of technologies and intellectual property. His credentials include:

• Accredited Senior Appraiser (ASA) by the American Society of Appraisers in Machinery & Technical Specialties: Energy, Environmental, and Manufacturing Technologies.
• Certified Fire and Explosion Investigator (CFEI) by the National Association of Fire Investigators.
• Fellow of the American Institute of Chemical Engineers.
• PhD in Chemical and Fuels Engineering from the University of Utah
• MBA in Finance from the University of Chicago
• BS in Chemistry from the University of Delaware
• Licensed Professional Engineer in over 20 states

Dr. Box Consulting, Inc. is one of the highest respected consulting firms dedicated to the Packaging industry. Since 2010, it has become a globally renowned source for packaging process improvement, purchasing, manufacturing, distributing, shipment, and packaging environments. Dr. Box Consulting Inc.'s clients include Fortune 1000 corporations around the world and the Governments of the United States, Afghanistan, Tajikistan and the Country of Georgia.  

Business Consulting Services:

Packaging and Business Improvement - Waste reduction, quality improvement, safety improvement, profit improvement, lean manufacturing, machine productivity improvement, overtime reduction, on-time-delivery improvement and many other business improvement areas. A global leader in Packaging Procurement results.

Packaging Design and Branding - Assess packaging lines, improve efficiency, reduce material cost, design cost-effective packaging utilizing better and more flexible designs to protect and display products.

Branding - Design packaging, proper color choice, placement and designs of logos, names of products, placement of wording on the product and packaging for cosmetics, food products, household goods and many others. 

Packaging Research - Market assessments to determine the viability of building new plants in specific areas, including economic analysis, trend analysis, assessment of potential competitors’ strengths and weaknesses, market pricing analysis, and determination of potential customers.

Randy Phares, President and CEO of Dr. Box Consulting, Inc., is a Packaging expert specializing in Corrugated and Folding Carton Packaging. He has over 30 years of progressive leadership experience in Packaging, Procurement, Shipping, Lean Manufacturing, Quality, Safety, Productivity, and Business Improvement.

Since he began his career in 1990, Mr. Phares has held almost every job in packaging operations. These include manufacturing, distribution, sales, design, safety, and transportation.

Mr. Phares has served as a consultant for the Technical Association of the Pulp and Paper Industry's (TAPPI) Consulting Council. He was also the Vice Chair of the Packaging Consultants Council for the Institute of Packaging Professionals (IOPP) and President of the South Texas Manufacturer’s Association. 

Mr. Phares has spoken and keynoted National, International and Local conferences. He has been hired to do DOT Packaging HAZMAT training for paper, rigid, and flexible packaging. Mr. Phares has done leadership training, Lean Manufacturing training, sales training, machinery training, new Supervisor training, safety training, and much more.

View Randy Phares' Expert Witness Profile.

Blue Silk Consulting specializes in Global Supply Chain Processes and Technology Enablement. We are a consulting firm, with 80+ clients and over 35 years of consulting experience in Supply Chain Management, Project Management, Systems Consulting, and Expert Witness Services. With global and domestic clients, Rosemary Coates has extensive knowledge and experience in manufacturing and outsourcing to China, and in global manufacturing strategies such as reshoring production. Rosemary Coates' experience spans a broad range of industries including:

Rosemary Coates, President of Blue Silk Consulting and the Executive Director of the Reshoring Institute. She is a seasoned executive with an MBA and 25+ years of experience in Chinese Sourcing and Manufacturing, Global Supply Chain Management, Reshoring, Procurement, Manufacturing and ERP Systems Consulting. Background Experience. 

Prior to BSC, Ms. Coates was a Senior Director at SAP, the Supply Chain Practice Leader at KPMG Peat Marwick and at Answerthink, and a Regional Manager at Hewlett-Packard. Ms. Coates has consulted with global and domestic clients, VCs, and PE firms on operations systems and processes. She has considerable international experience and has worked for extended periods in Asia and Europe. 

Ms. Coates' experience spans a broad range of industries including High Technology, Software, Chemicals, Health Care, Consumer Products, Industrial Products, Food Distribution, Transportation, Publishing, Retail, and Oil and Gas. She has extensive knowledge and experience in manufacturing and outsourcing in Asia, Europe, and the US. She has written five Amazon.com books including Best Seller 42 Rules for Sourcing and Manufacturing in China, and Legal Blacksmith: How to Avoid and Defend Supply Chain Disputes, and  42 Rules for Superior Field Service, and Negotiation Blueprint for Buyers, and The Reshoring Guidebook. 

Ms. Coates is also the Executive Director of the Reshoring Institute and a member of the Board of Directors at the University of San Diego Supply Chain Management Institute, and a Member of the Board at Kinectic River. She teaches Global Supply Chain Strategy at UC Berkeley. She is a Licensed U.S. Customs Broker. She earned a BS in Business at Arizona State University and an MBA at the University of San Diego. She resides in Silicon Valley.

Rosemary Coates: Supply Chain Management Overview

Areas of Expertise:

View Rosemary Coates' Expert Witness Profile.

Biernath Consulting helps small to midsized companies envision how AI and other advanced science & technology can help grow their business. He helps them create and implement innovative solutions to achieve success.

Rolf Biernath, PhD in Chemical Engineering, has over 30 years in the Chemicals and Electronics Industries with a concentration on AI advanced technology new product development. He developed new products and product lines at 3M for 31 years in senior technical roles. His 58 issued US patents span a broad range of scientific and engineering disciplines. 

Rolf has a strong drive to find the simplest and most effective solutions that meet customer needs and business objectives. His broad technical background and his resourceful ability to learn new fields quickly make him an ideal partner to help turn product's into fully realized new products and services. If it can be done, he'll find the way. If not, he'll tell you why, and let you know what advances might enable it in the future.

Rolf also works with VC and Angel Investors to assess a startup's new technology odds of technical and business success. He is known for his ability to break down complex technical problems and find the critical aspects that will make or break a new product. This helps investors ensure that financial investments are used to target the highest risks first, thereby reducing the money and time wasted chasing after products that may likely never see the light of day.

Consultant Specialties:

Background Experience - Dr. Biernath has 58 Issued US Patents on New Products, including:

• Industrial Adhesives and Tapes – 3D printing materials, development, automation, and tape application processes
• Electronic Displays and optical display films, outdoor digital displays, backlights, LED color mixing
• Electronic Materials, epoxy thermoset adhesives, application process, elastomeric, high speed electronic connectors
• Signage, retroreflective signage, license plate recognition, ADAS, Human Invisible, Machine-Readable Coding System
• IoT and IIoT, Automatic and predictive selection and replacement of controllers, novel low-cost oil-detection sensor
• Microreplication, microfluidics, textured adhesives and processes

View Dr. Rolf Biernath's Expert Witness Profile.