ROBERT F. DREAM

***** ***** ***. **********, ** *5241. ddigot@r.postjobfree.com. 513-***-****

SUMMARY

• Over 29 years of experience, with 15 years executive leadership experience, in the consumer product, pharmaceutical, biotechnology, and life sciences industries

• Experience entails manufacturing, operations, R&D, Scale-up, product launch assistance, regulatory, marketing, leadership, project management, merger & acquisitions, facility & process consolidations, and many years of consulting

• Lead and managed projects with clients to improve processes, scale up products and operations through lean manufacturing, through operations and technology knowledge, and through developing, translating, and executing supply chain and manufacturing strategies and FMEA

• Strong business and functional knowledge of manufacturing, warehousing, logistics, supply chain, risk management, project management, operations know how of many different type of industries including biopharmaceutical and pharmaceuticals

• Experience includes process development, finance acumen, supply chain management, regulatory affairs, quality assurance, and quality control, developing and implementing processes, systems, and standards used for establishing and managing contract manufacturing relationships

• Aided many start-up firms on product development and advanced their operation from lab/R&D/pilot plant into manufacturing

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WORK EXPERIENCE EXCERPTS

X-nth/exp 2010 – 2011

Vice President, Pharmaceutical & Biotechnology

• Responsible for the pharmaceutical and biotechnology business sector to grow and expand market share globally of the firm

• Project advisor and chief process engineer for a manufacturing facility for Texas A&M Systems, National Center for Therapeutic Manufacturing, College Station, Texas, USA

o Over 163,000 ft2 includes academic, research laboratories, cGMP training and multiple product biologics manufacturing up to Phase III clinical manufacturing.

o The facility supports cell and microbial based protein expression, viral vector gene therapy and autologous oncology vaccine manufacturing, purification and final product sterile filling

• Project advisor and chief process engineer for the $61 million dollar facility using plant-based technologies for production of low-cost influenza vaccines for GreenVAX, Expressed Vaccine Consortium, Bryan, Texas, USA

o Plant Growth and Inoculation, Plant harvest, Down Stream Processing Design, process flows, instrumentation & Control, and piping layouts.

o The projected final scale capacity of the facility is 100 million doses per month.

o Exp provided process engineering services for the Harvest and Waste Treatment areas of the facility, including process equipment layout, P&ID development, and equipment selection

• Performed as project director for a R&D, Lab and pilot plant to develop and manufacture e-coli and yeast based products for Diabetic Medication for Novo Nordisk, Beijing, China

• Developed several pilot plant conceptual design, space definition and funding requirement, e.g.: Lavonia, ARE, and Founders for several clients in Beijing China

• Several Pharma/Biotech Parks at 10K ft2 each (five), China several locations

Independent Consulting 2007-2009, Present

• BioMimetic Therapeutics Inc., Nashville, TN

o Project director of project to plan, budget, design, procure, and construct a $30MM sterile syringe and vial manufacturing facility with all the necessary support and amenities

• Dr. Reddy Laboratories, India

o Performed PAI mock-up Audit/GAP Analysis to meet requirements for US-FDA and EU-EMA regulatory

o Documented a GAP analysis for a newly completed Cytotoxic Sterile manufacturing facility

• Therapuces LLC, Moorpark, CA

o Partnered with a start-up company which had patented new technologies to improve product yield to find financial support, to find products to utilize their technology, and to find a facility to manufacture

o Investigated the market and teamed up with a company with an established presence in China to provide funding for building the needed manufacturing facility

o Persuaded China’s VC’s to fund the design, build the facility, and provide operational funding for five years. The overall cost was in the range of $43-50MM

• Amylin Ohio LLC, West Chester, OH

o Assisted with cycle development protocol write-up/execution and IQ/OQ Protocol review and execution

o Provided technical assistance during the cycle development and microbiological qualification as well as troubleshooting failures during execution of qualification/validation protocols

o Resolved technical issues arising from installation through process validation. Reviewed documents, drawings, procedures, and plans

o Assisted in regulatory compliance documentation and compilation, performing engineering runs, process qualification execution, and media runs and process validation

Lockwood Greene, Dublin, Ireland, & Hague, Netherlands 2002 – 2006

Director of European Operations

• Overhauled the Lockwood Greene European Operations P&L, expanding the operation and its capabilities

o Marketed company services to clients and won new projects to improve backlog and declining revenue

o Redirected the company and improved/grew operations in five to seven months through better servicing existing clients and bringing in new clients and new projects

o Built up the office’s technical capability to provide services to clients

o Restructured management as well as the finance and legal departments

• Lead a €120MM project with the Irish government planning, detailing, and designing a biotechnology incubator facility to house four independent research laboratories to be used by researchers and students attending the universities in Ireland

o Facility was to house a microbial manufacturing line, a cell culture manufacturing line, and a multipurpose line, and had a fully stand alone functional building including, administration, process support, utility systems and an auditorium for teaching/lecture

o Provided all the needed plans, presentations, operational planning, organizational requirements, staffing, and cost for the facility

o Provided the needed technology background, planning, engineering, and construction for start-up and five year operation

o National Institute for Bioprocessing Research and Training (NIBRT), winner of the Facility of the Year Award Special Recognition for Novel Collaboration for its New Greenfield facility in Dublin, Ireland

• Lead projects with Dublin City University, University College Dublin, Royal College of Surgeons in Ireland, Dublin Molecular Medicine Centre, Dublin Institute of Technology, and National University of Ireland, Galway to plan, perform concept development, design, cost model, engineer, construct, and qualify facilities for R&D, clinical material, and small scale manufacturing

o Facilities were to manufacture cell biotechnology, rDNA, Adenoviral incubated products, Monoclonal Antibodies (MAb), etc.

• Lead a 5.5MM project assisting GlaxoSmithKline to determine if building a new facility (Cost 85MM) was necessary for a product that had SKUs manufactured in 25 countries and that was packaged and distributed in approx 80 countries

o Compiled and analyzed data on manufacturing, equipment, and equipment capacities as well as historical manufacturing data from the existing plants and the manufacturing time line

o Based on the analysis deduced approximately seven scenarios/options were possible to respond to the marketing need

o The study eliminated the project and added the needed future capacity in addition to streamlining existing operations and replacing bottlenecks

• Lead a €30MM project with Cross VetPharm (Dublin, Ireland) which had been given a 167 page warning letter for a two line syringes manufacturing facility for not being in compliance

o Read and classified items in the letter in categories of importance to be addressed and proposed a solution to the client

o Sold the proposal to the executives

o Formulated a solution package (drawings and descriptions) and meet with/presented the proposal to the regulatory body in Dublin resulting in a solution that was sound and more than sufficient to bring the facility in compliance

o After two years and adding two new lines to the facility, the facility went back on line to manufacturing product and distribute all over EU and US

• Lead a €70MM project with Wyeth Medica Grange Castle-Ireland for the project planning of a cell culture development facility scale down to 500 litre reactors from concept development through construction

o Developed a scale down processes to mimic existing operations of Embrel and other cell culture and fermentation processes to improve harvest yield

o Increased the manufacturing yield five folds through the process development

o Reduced the reactor size requirement from 25,000 liters to 5,000 liters to manufacture the same amount of product for future planning.

• Lead three projects with Abbott, Sligo, Ireland

o Projects involved solid dosage manufacturing, API manufacturing, and sterile multi-container fill (vials and ampoules) products

• Lead a project with Lake Region, New Ross, Co. Wexford, Ireland for Fit-Out for Guide Wire Assembly, a surgical medical device manufacture facility

• Lead four projects with Schering Plough, Ireland

o Two projects involved API manufacturing projects, a liquid and gaseous chemical storage and handling project, and a HAZOP project

• Lead a project with Seagate Technologies, Londonderry, Northern Ireland for the oversight of design and construction of a Wafer Fabrication Plant.

• Lead a €30MM project with Taro Pharmaceutical, Roscrea, Co. Tipperary, Ireland for Sterile (vials) Manufacturing of multi-products

Lockwood Greene, Various Locations 1997 – 2001

Director of Pharmaceutical/Biotechnology Operations

• Brought on a board to diversify the Cincinnati office with 200 employees, $26MM Gross Income, with multi-projects size ranging from $3K to $50MM

o Office was 100% dedicated to performing services for P&G

o Converted the operation partially to a non-P&G projects base for office stability

o Diversified the office to 70% performing work on a non-P&G projects in six months through rigorous marketing, applying experience and know-how of the Pharma/Biotechnology industry, presenting technologies applications, manufacturing, and operations know-how to bring in new clients and projects

o Project total book value approx $260MM

• Opened and operated new office/operation for Lockwood Greene to provide services to clients in Sao Palo, Brazil

o Office was operational and self sustaining in a one year’s time (with approx 200 employees)

• Secured and managed a $175MM project with HMR (later Aventis, today Sanofi-Aventis) to consolidate their operations in the Mercosur area in one operation in Suzano, Brazil

o With one additional person planned, designed and built one of the most automated facilities for the company

o Facility was to manufacture all SKU’s that Aventis had in their product pipe line

o Facility was designed to have a four level spine servicing all manufacturing facilities that is connected off the spine, an automated shipping and receiving building with use of AGV’s, an ASRS high rise warehouse, a solid dosage building, a Liquid Manufacturing Building, an upgraded existing sterile manufacturing building, three laboratory buildings, and an admin building

• Completed and restructured an acquisition in Argentina for Lockwood Greene

o Acquired company was an engineering operation performing services for the textile industry, which was non-existent in Argentina

o Goal was to take the operation and convert it to an engineering house that performs service for the process industries i.e.: Pharma, Biotech, Chemicals, Oil, etc.

o Operation was completed successfully in record time

• Secured and provided technology and regulatory input to a $30MM solid dosage manufacturing project with Roche in Pillar, Argentina

o New facility was to replace the existing Boehringer Mannheim facility (acquired) that was facing scrutiny from regulators and had been shut down

o Project completed in two and half years and produces the entire product line for Roche in the Mercosur area

• Opened a satellite office in Rixensart Belgium for Lockwood Greene to provide project and technology services for Smithkline Beechum Biologicals

• Secured a project with SB Biologicals to assist on their vaccines and other biological products (around 40 products in the preclinical/clinical stage and existing product operation expansions) to plan for manufacturing

o Provided technology transfer from clinical to manufacturing

o Formulated a manufacturing scheme to be built in Wavre, Belgium and Singapore

• Secured a project providing master planning and basic engineering design on a 16.5 Hectar site, in Singapore performing the services from Belgium and Somerset, USA

o Site was to have 5 to 10 year build out plan (five phases)

o First phase of this project included an administrative building, a small warhouse (expandable), vaccine formulation and conjugation building, primary and secondary packaging and inspection building, and a supporting utility building

o Future phases were to include cell culture manufacture, microbial fermentation, and viral incubation processes.

o Total build of the site: approx €2B

• Worked on a $650MM project for Immunex, West Greenwich, Rhode Island for Enbrel Phase B Expansion (BioNext). The project was designed by Kvaerner/Kinetics and was to be constructed by Turner construction or an equivalent.

o Plant was to operate independently and was to be self-supporting. Project entailed all the support functions i.e. media, buffer preparation, and downstream processing units (harvest and purification)

o Evaluated the integrity of the process and control

o Evaluated E-TIC (Estimated Total Installed Cost) of the project for budget appropriation and construction bid

o Worked on an audit team of seven members. The other six members of the team evaluated HVAC, architecture, piping, utilities, civil/structural, and project schedule

Rust International, Inc., Birmingham, AL 1995-1997

Vice President Biopharmaceutical Division

• Joined a well established company that was a leader in performing process projects for clients in the chemical, pulp and paper industries

• Vice President position was created to start a division that services the Pharma/Biotech industry

• Successfully created a group of approximately twenty employees, establishing projects, and utilizing the common pull of employees for the general service

The Sigel Group PLC, Narberth, PA 1993-1995

Director of Process and Validation Department

• Expanded the company’s capabilities in the Pharma industry to provide process and validation services to their clients

• Consolidated thirteen facilities in seven European countries for Wyeth operations into one operation in Newbridge, Ireland

o Managed a team of engineers, external experts and vendors ($200M+ Project) to develop site search/selection, integration, design, construct and validate the facility

o Lead the project from finding the site, design engineering, construction and validation

o Project constituted of four major manufacturing suites grouping products based on their commonalities

• Consolidated Schering plough Latin America operation in one facility in Xochimilco, Mexico

o Managed a team of engineers, external experts and vendors to develop the design of facility integration

o Lead the project from site master planning, engineering, and construction

o Project constituted of four major manufacturing suites: sterile manufacturing, solid dosage manufacturing, liquid-suspension- topical-ointment-cream manufacturing, and animal health manufacturing products

• A few other noteworthy projects include: Vestar (two line Sterile Manufacture of Cytotoxic liposome products), Glaxo (few OSD and biologics projects), Roche (the 2001 project of the future), Merck & Co., Inc. (the first Isolator technology project with FDA, Eli Lilly, Upjohn, Smith Kline Beachum and few vendors; and an animal health project, etc.)

Fluor Daniel, Marlton, NJ (Fluor) 1990-1993

Lead Engineer/Manager of Small Projects

• Joined the company on a client request from DuPont-Merck to develop and design the facility at Chambers Works, NJ for a $200MM project and to assist on the planning and design of the sterile manufacturing facility in Puerto Rico

• Ran an operation of small projects (projects up to $30MM) and reported to the Vice President of Pharm/Bio division

• Ran a division of 85 employees for 18 months very successfully, working with American Home Product, Ron Poulenc, Merck & Co., Inc., AKZO Nobel, Hagen Dazs and other firms

• Provided excellent and affordable service through sharing the overhead between the projects to reduce total overhead

• Managed clients through running on schedule and budget

Triad Technologies Ltd New Castle, DE 1988-1990

Principal/ Director of Engineering Department

• One of six people that established a service company to aid the biotech and sterile manufacturing industry, providing a specialized service in both process and validation

Stone & Webster, Cherry Hill, NJ 1982-1988

Lead Engineer/Principal Engineer/Project Manager

• Joined the company starting as project manager for leading design groups on large projects

o Directed designs, initiated and reviewed drawings and design planning, approved design drawings, and engineering documents, etc.

• Responsible for weekly budget, scheduling and progress reporting on projects

• Principal Engineer with increased responsibilities including technologies applications, marketing functions, client meetings, and regulatory meetings

• Promoted to Project Manager/Director, managing projects up to $968 MM with 480 employee’s direct reports

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EDUCATION

Illinois Institute of Technology, Chicago, IL; (BS), Mechanical Engineering, May 18, 1980

Illinois Institute of Technology, Chicago, IL; (MS), Mechanical & Aerospace Engineering, August 7, 1982

Drexel University, Philadelphia, PA; (PhD), Biotechnology Engineering Degree, 1983-1988

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PROFESSIONAL AFFILIATIONS

• Registered Professional Engineer - NJ, PA, MA, NC, TX

• Active member of ISPE, PDA, Pharmaceutical Processing Editorial Advisory Board, Pharmaceutical Manufacturing Editorial Advisory Board

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PUBLICATIONS/PRESENTATIONS/CERTIFICATIONS

Complete list available upon request

• Numerous publications: papers, books, biotechnology columns

• Numerous presentations and lectures (short and long sessions) at numerous organizations, societies, and Universities

• Several Continuing Education and Management Certifications, Contracting and Negotiation Certification

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