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Engineer Manager

Location:
Gainesville, FL
Posted:
October 27, 2012

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Resume:

Title:Graduate Research/Teaching Assistant

abpd7z@r.postjobfree.com

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NAME:,

ADDRESS:

ADDRESS2:

CITY:

STATE: FL

ZIP:

CANDIDATE ID: 2878534

US CITIZENSHIP:

EDUCATION:

EXPERIENCE: 0

WILL RELOCATE: No -

JOB WANTED:

RATE NEEDED:

TELEPHONE: 352-***-****

EMAIL: abpd7z@r.postjobfree.com

HOMEPAGE:

COMMENTS:

HOTTEST SKILLS: product, engineer, medical, database, emergency, organic, pharmaceutical,

cisco, campaign, communication, growth, inventory, sale, chemist, chemistry, clinic,

clinical, health, hiv, laboratory

REVISION: 08-SEP-02

RESUME:

NAME: WILLIAM DOWNS

ADDRESS: GAINESVILLE, FL 32605

CITY: CITY:

STATE/PROVINCE: CITY:

ZIP/POSTAL CODE:

COUNTRY: USA

EMAIL:

PHONE: 352-***-****

CANDIDATE ID: NA

CITIZENSHIP: US

Citizen

EDUCATION: Not Entered

EXPERIENCE: Not Entered

WILL RELOCATE: Not Entered

RELOCATION INFO: Not Entered

JOB WANTED: Any

RATE NEEDED: Not Entered

HOMEPAGE:

COMMENTS:

HOTSKILLS:

WILLIAM B. DOWNS

3430 NW 31ST TERR.

GAINESVILLE, FL 32605

^352-***-****

abpd7z@r.postjobfree.com

OBJECTIVE

Continued involvementwith the chemical, medical device or

pharmaceutical industry where I can contribute to the development of

processes/products by using proven strengths in research,

conceptualization, evaluation and problem solving.

CAREER SUMMARY

Background& experience in manufacturing bulk pharmaceutical chemicals

and medical devices with specific experience in:

Technology transfer from R&D to manufacturing Bench scale & pilot

plant production (1g-200kg) Batch process scale-up issues Production

schedules and employee supervision Crystallization techniques Designed

experiments Process modeling using ASPEN+ Equipment/Process validation

QA/QC Manager

U.S. Operations Biodynamics Inc.,U.S. Alachua, FL

(7/96

-7/97) Wrote and established the Quality Assurance program in

compliance with FDA regulations and American Association of Tissue

Banks standards for processing human tissue into medical dev ices.

Conducted internal and external GMP audits relevant to vendors and

processing facilities. Aligned policies and procedures to obtain

certification by the AATB. Designed and implemented an Access database

and bar-code system for inventory control and tracking donor to

recipient information.

Production Manager

Farchan Laboratories Gainesville, FL (7/95 -4/96)

Planned production schedules and supervised a two shift batch

production operation that manufactured a range of specialty

organicchemicals for catalog sales. Increased the production capacity

by 2500y designing and coordinating the installation of a new

reactor system within the existing manufacturing facility.

Sr. Process Development Engineer

G.D. Searle Skokie, IL (7/92 - 12/94)

Acted as lead engineer during the production of Bidisomide (an

anti-arrhythmic drug manufactured in an eight step organic synthesis)

and was heavily involved in transferring the technology from the R&D

site to the production facility in Georgia where product launch

supplies were made. Led a team of three to five process development

engineers when two HIV protease inhibitors and one LTA4 hydrolase

inhibitor were brought forward. Modified, improved or adapted chemical

syntheses when they were scaled-up from bench scale (1-100 grams) to

the pilot plant (1-200 kg) and manufacturing scale (Phase I & II

clinical supplies). Planned production campaigns, assessed corrosion,

waste and safety issues, calculated raw material requirements and

designed equipment modifications. Conducted statistically designed

experiments for improving crystallization protocols on several

processes and presented one study at the AICHE annual meeting (San

Francisco11/94). Computerized the approach for writing batch records

leading to standardized documents from the process engineering group

when the number of projects was increased by 300%. Evaluated several

process modeling systems and chemical databases leading to the lease

of ASPEN+ software.Initiated the installation on a VAX network with PC

interfaces and subsequently trained other process engineers in using

the software. Performed the role oftechnical representative when

chemical intermediates were tolled out to independent manufacturers.

Registered Sanitarian

- Blaine County Health Dept. Chinook, MT 11/86 -

9/87

Self employed

- Construction Helena, MT 4/83 - 9/84

U.S. Peace Corps

- Mathematics, and Chemistry Sabah, Malaysia 9/79 -

4/83

Process EngineerProject

Lignite Dept. of Energy, Grandforks, ND 7/75 -

8/79

Shared in the development of new processes to produce petroleum

feed-stocks from coal. Designed, modified and installed process

equipment that could be adapted to the pilot plant scale.

EDUCATION

Auburn University,

Auburn, Alabama - Ph.D.Chemical Engineering 9/87 -

12/92

Secondary Growth of Carbon Filaments from Parent Fibers for the

Development of 3-D Preforms.

Montana St. University,

Bozeman, Montana - M.S. Chemical Engineering

9/84

- 3/86

Montana St. University,

Bozeman, Montana - B.S. Chemical Engineering

9/71

- 6/75

AFFILIATIONS & AWARDS

Member of the American Institute of Chemical Engineers. Member of the

American Association of Tissue Banks Award for Contributions that are

Exceptional G.D. Searle - $1000 Granted for the standardized and

streamlined method of writing operation records. Award for

Contributions that are Exceptional G.D. Searle - $2000 Awarded for the

technical transfer of Bidisomide into manufacturing and Emergency

Response activities New Ideas ProgramG.D. Searle - $100 Recognized for

ideas on electronic batch records and bar coding documents.

PROFESSIONAL TRAINING

Crystallization Techniques - AICHE Validation by Design Statistical

Design of Experiments Process Safety Management - PSM The Assertive

Manager Total Quality Management - TQM Quality Systems Regulations

NATOAdv. Sci. Inst. - Applied Sciences Hazard Communications training

- HazCom Crystallization Technology - SPS Good Laboratory Practice

training - cGLP Good Manufacturing Practice training - cGMP Training

the Trainer Emergency Response Organization Incident Command training

Hazardous Material Technician certification Fire Safety training

Medical Device Design Control



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