David G Nelson, Pmp Email & Phone Number

East Falmouth, Ma, Us

Boston, Ma, Us

-Applied Biotechnology Study: biotechnology essentials, bio lab practical, medical terminology, business of biotech, clinical research, laboratory management, Agile project management -Internship on adaptation of HEK 293 mammalian cells from Invitrogen to Hyclone serum-free media in process development of human antibody production. Part of team project to optimize small scale plasmid transected antibody manufacture.

Forchheim, De

-Process manfacturing support (MIRs, CAPAs, VECOs)-New process equipment specification and installation-Process improvement-Process and equipment validation-Validated 150 existing and new Temperature Controlled Devices (TCDs) that never had been qualified. -Capital projects management: process and equipment-Responsible for site 350+ TCD Program including specifying, installing, qualifying, maintaining, repair troubleshooting, and managing change.-Planned and executed remediation project for failed -40 degree Celsius Gold Standards walk-in cold box. Located, setup, validated rental freezers, executed controlled relocation of regulated freezer contents for repairs, revalidated freezer, returned to service, and established preventative maintenance plan for all 25 site walk-in cold boxes.

Charlotte, North Carolina, Us

-Designed pre-condenser/vacuum system for caprolactam dehydration column increasing plant capacity by 30 MM lb/year ($6 MM/year).-Operated 1/20th scale Fenton’s Reagent pilot plant to destroy color components in purified caprolactam. The quality and production increase was valued at $20 MM/year.-Reduced major plant safety and environmental incidents from 27 (2001) to 16 (2002) through the plant’s incident investigation review committee.-Designed and installed a $2 MM Compliance Order Project for the VA EPA.-Designed a catalyst recovery furnace system with electrostatic precipitator saving $4 MM/year.-Acted as mentor to three recently graduated engineers and supervised engineering co-op students.

-Completed technical proposals to retrofit two new catalyst processes into existing process lines. One process involved specifying the scope for a new plant. Defined equipment material balances, project scopes, capital costs, and project economics.-Completed process and project engineering on a $400 K plant expansion.-Completed the engineering packages for nine “management of change” projects totaling $175 K.-Modeled batch process to make expansion recommendations. Defined incremental project scope, cost, and economics for each proposal option.-Completed all process engineering on three separate catalyst plant expansion projects to increase total production by 180 K lbs/yr. Generated $27 MM/year of gross revenue. Project spending was under budget at $9.5 MM with the debottlenecked train estimated at another $8 MM. -Facilitated the commercialization for 11 new custom catalyst products. Process responsibility for all unit operations including: crystallization, spray drying, extrusion, impregnation, exchange, and calcinations. Responsibilities include: customer interfacing, OSHA and DOT compliance, writing operating procedures consistent with ISO 9002 standards, operator training, setting up production models and analytical testing, tracking unit operation yields, startup and troubleshooting assistance.-Plant liaison on cross-functional new product development team to commercialize a new catalyst. Responsibilities included environmental modeling and air permitting, estimating unit costs, and completing pilot trials.

- Responsible for technical and operations functions for eight specialty chemical processes.- Successful startup of a ten-step metal oxime chelant plant- increased yield from 15% to 53% in the first 5 months of operation.- Startup of a bulk drug intermediate chemical process with adherence to FDA and cGMP requirements.- Increased production of a bulk drug intermediate chemical process by 60% to meet market demand resulting in a $3 MM annual contribution. Productivity increase was due to yield improvements and better equipment utilization through cycle time reduction.

Post Undergraduate Certificate, Applied Biotechnology

Ms, Systems Engineering

Bachelor Of Science - Bs, Chemical Engineering

Education record