Project Manager/Director

Ganga De

* ******* ****, **** *******, NJ ***** | (H) 609-***-**** | (C) 609-***-**** | *******@*****.***

Summary of Experience and Skills

• B.S. in ME and 25+ years of project management and engineering experience.

• Managed several medium to large EPC capital projects successfully utilizing DFSS.

• Prepared project plans that included scope, schedule, estimating, EH&S, quality, risk mitigation, engineering, procurement, construction and validation.

• Familiar with various regulations such as DEP, NEC, EPA, FDA, OSHA, NFPA and European regulations on fill-finish projects.

• Skills in and familiarity with software including MS Project, MS Office, Primavera, Timberline, Monte Carlo, and AutoCAD.

• Executed complete project cycle including layout, flow diagrams, technical specifications, design drawings, vendor selection, management of contractors/vendors, material and maintenance services, startup/commissioning and validation support, and final operation handover.

• Excellent team player and a leader; have worked effectively with management of engineering, procurement, construction, administrative staff and vendors, and supported business development and operations personnel.

• Expertise with written and oral presentations to stakeholders.

• Facilitated preparing and approving invoices and tracking AR/AP.

• Experience in building and enhancing client relationships, enhancing market share by supporting business development, bringing positive outcomes on gross margins.

• Worked on projects involving energy audit, conservation and sustainability issues.

Professional Experience

SENIOR PROJECT MANAGER, INTEGRATED PROJECT SERVICES, SOMERSET, NJ 2011-2012

• Bausch and Lomb, Rochester, NY

o Site Master Plan project for addition of the state of art lens manufacturing lines. Developed various options for evaluation to determine the optimum choice that meets business and operations objectives. Various flow diagrams e.g equipment, material, people etc. were developed along with cost estimates for each option. The areas were designed as GMP but were not classified as the manufacturing lines were fully enclosed.

• DSM Nutraceuticals, Belvidere, NJ

o Responsible for Land Development approval from township for Optima packaging line project.

• Forest Laboratories, Hauppauge, NY

o Responsible for design of a 4000 square feet Flexible Laboratory. The analytical laboratory was designed GMP but not classified. Various flow diagrams were developed to ensure there is no cross contamination.

SENIOR PROJECT MANAGER, CH2MHILL LOCKWOOD GREENE, SOMERSET, NJ 2005-2010

• Pfizer – Kalamazoo, MI

o This project involved an aseptic fill/finish facility qualified and completed in 2010. The scope covered detail engineering, construction support and qualification. Saved considerable capital cost via value engineering process. Achieved regulatory compliance through development and execution of qualification protocols. Developed appropriate flow diagrams for people, materials and equipment, HVAC zoning and pressurization diagrams to ensure contamination-free facility. Completed the project successfully under budget. TIC: over $100MM

o Performed basic engineering including preparation of a definitive estimate for formulation suites in an aseptic fill/finish facility involving suspension products. The project considered using isolator for charging materials to the formulation tanks. Considered regulatory compliance and flow diagrams for people, materials and equipment in the development of layouts. The multi-office execution was carried out via project website, net meetings, teleconferences etc. The project scope was completed under budget. TIC: $10MM

• Schering Plough – European Projects

o Conducted front end studies for fill/finish facilities of sterile suspension and solution products involving vials, syringes and ampoules. The challenge of these projects was to develop various layout options within a confined available space at the lowest cost. Regulatory compliance and flow diagrams for people, material and equipment to avoid cross contamination were considered for layout development. The study was completed successfully under budget and on schedule. TIC for two projects: $120MM

• Amgen – Seattle, WA

o Performed engineering and design to support a facilities expansion of one million square feet of laboratories, office spaces, waste treatment facilities and parking garage. Prior to starting the master plan, the project required an energy audit. The engineering was completed successfully under budget and on schedule. The multi-office execution was carried out via project website, net meetings. TIC: $40MM

• Honeywell, Specialty Materials Group – Morristown, NJ

o Completed basic engineering and definitive estimate for the Apollo pilot plant in BRL, Buffalo, NY under budget and on schedule. The project challenge was to formulate an optimal strategy to build the facility while maintaining existing operations. This was accomplished via development of various construction scenarios with estimated cost. TIC: $10MM

• Sanofi Pasteur – Swiftwater, PA

o Completed a design study for a packaging line under budget and on schedule.

DESIGN MANAGER/CONSULTANT FOR AEROTEK AT PFIZER, PARSIPPANY, NJ 2004-2005

• Pfizer - Parsippany, NJ

o Initiated a state-of-the-art project for the Parsippany Technical Center, involving a 200,000 ft2 facility for offices, pilot plant and laboratories. The project's challenge was to relocate existing pilot plant equipment and lab instruments from another site to save cost. This was carefully planned with representatives from manufacturers and vendors. The work required supervision of outside AE firms. The front end package including a definitive estimate was completed successfully. TIC: $65MM

PROJECT DIRECTOR, KVAERNER, BRIDGEWATER, NJ 1979-2004

• Merck - Rahway, NJ

o Performed detail engineering and provided construction support for "Small Scale Organics two-bay fit-out" project. This organic synthesis project served as a pilot plant for clinical trials of new drug development. Worked with construction manager as a blended team and earned Merck's bonus for completing this project within the critical schedule. The project employed 3D PDMS model. The validation covered master plan, and IQ, OQ, and PQ protocols development and execution. The project included clean room operations and required regulatory compliance. TIC: $50MM

o Provided engineering for solids handling projects for the Small Scale Organics (SSO) facility. The project required containment of level 3 compounds. Developed and evaluated several options to choose the lowest cost option. The project required clean room considerations. TIC: $20MM.

o Performed engineering and validation services for a Large Scale Organics (LSO) renovation project. The validation effort included development and execution of IQ, OQ, and PQ protocols. TIC: $10MM

o Performed engineering and provided construction support for bio-catalysis and continuous sterilizer projects. Completed engineering under budget and on schedule. These projects required clean room considerations and regulatory compliance. TIC: $10MM

• Merck - Danville, PA

o Provided engineering, procurement and construction for Xanthan Gum® project. Performed construction on the basis of lump sum subcontracts. The project was completed successfully under budget. TIC: $100MM

• Medarex - Bloomsbury, NJ

o Completed a very fast-track developmental laboratory that included a bio-pharm lab, QA/QC lab, purification lab, and offices. The project was completed in record time, enabling Medarex to mobilize R&D personnel as planned. The challenge of this project was to execute engineering work in parallel with construction of the facility on a fast track basis. This was accomplished by working with construction manager as one team. The project required regulatory compliance for clean rooms. Layout was developed based on flows for people, material and equipment to avoid cross contamination. TIC: $20MM

• Anaquest Caribe Inc. - Guayama, PR

o Provided engineering, procurement, construction and validation services for an anesthesia production facility at Anaquest Caribe's existing site in Guayama, Puerto Rico. Utilized CMA Associates, a local company to perform limited facility design and secure building permits. Developed Validation Master Plan, IQ, OQ, and PQ protocols and then executed protocols at the site. The project required regulatory compliance. The layout considered various flows e.g. people, materials and equipment to avoid cross contamination. Completed this project successfully under budget and on schedule. TIC: $120MM

• DuPont - Wilmington, DE

o Performed engineering for an advanced drug delivery system launch project for a confidential product. DuPont intended to use this product as an intermediate in the development of a final drug. The challenge to this project was to keep up with incoming data from the laboratory, and to develop a design that required a combination of 5,000 psig pressure and clean room class-10,000 area for the process. Adopted a modular design to provide mobility of the skids planned to be housed in a leased cGMP facility. Managed multi-company execution successfully. Validation work included development and the execution of master plan, IQ, OQ, and PQ protocols. TIC: $5MM

• DuPont - La Porte, TX

o Performed engineering, provided procurement and construction support for a fully enclosed and highly automated phosgene plant. Earned bonus for successful completion of the project under budget and on schedule. TIC: $15MM

• DuPont - Parkersburg, WV

o Performed engineering, procurement and construction services for a polymer compounding project at Washington Works facility. The polymers handled were Rynite®, Zytel®, etc. The project was completed under budget and on schedule.

TIC: $50MM

• Huntsman Chemical - Woodbury, NJ

o Performed engineering, procurement and construction management for the polypropylene plant conversion project utilizing high activity catalyst (HAC). The project's challenge was to comply with contractual bonus/penalty clause of minimizing operating downtime. This was achieved by carefully planning shutdown work with all materials procured and employing double shift construction with controlled overtime. Earned full bonus as downtime was minimized. TIC: $12MM

• Searle Food Resources - Park Forest South, IL

o Provided engineering, procurement and construction for an artificial sweetener plant, the first of its kind. This project was built in an existing facility with five trains in record time. A site based engineering team supported construction on a fast track basis. Performed construction on the basis of lump sum subcontracts. TIC: $35MM

• Pfizer - Barceloneta and Vega Baja, PR

o Provided front end engineering services for site master plan. The work was completed within schedule and under budget.

o Completed engineering for an existing finished pharmaceutical facility for the drug Troglitazone®. Executed engineering at the site to support construction.

TIC: $10MM

• Rhone-Poulenc - Institute, WV

o Provided front end engineering support for a containment facility. The plant handled various hazardous chemicals, e.g., phosgene, chlorine, and isocyanide. TIC: $90MM

• Hanclor Corporation - Edison, NJ

o Performed engineering, procurement and construction for a sodium chlorate project in Syracuse, New York. This project was based on Kvaerner/Chemetics proprietary technology with third party financing. TIC: $50MM

• American Cyanamid, Chemical Division - Kalamazoo, MI

o Performed engineering and design for a liquid based polymer plant project. The engineering was completed within budget. TIC: $15MM

• Mobil Research and Development - Paulsboro, NJ

o Performed detail design and provided construction support for fluid catalyst pilot plant project. TIC: $10MM

• Mobil Oil - Paulsboro, NJ

o Provided engineering services for crude unit #3 vacuum tower modifications project. TIC: $5MM

• Rollins Environmental Services - Bridgeport, NJ, Baton Rouge, LA and Deer Park, TX

o Provided front end engineering services for various environmental projects.

Education and Training

B.S., MECHANICAL ENGINEERING

• University of Calcutta, B.E. College – Calcutta, India

GRADUATE STUDIES - M.S. - MECHANICAL ENGINEERING

• New Jersey Institute of Technology – Newark, NJ

PROJECT MANAGEMENT TRAINING

• Cranfield School of Management – United Kingdom

QUALITY EDUCATION SYSTEM

• Philip Crosby Associates Quality College

OSHA SAFETY TRAINING COURSE

• CH2MHill University

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