Quality Manager

William J. McShane *********@*****.***

**** ******* **. ***-***-

**** (H)

Lawrenceville, GA 30043

770-***-**** (C)

1

Profile

Innovative PhD. in Chemistry (Analytical, Inorganic, Organometallic,

Organic) with strong expertise in bringing technical value into supporting

commercialization of product. Well-versed in strategic planning, continuous

process improvement, critical thinking, and problem solving. Proven track

record of leading successful project teams. Possesses a strong customer

orientation.

CHEMISTRY: analytical, inorganic, organic, organometallic, trace analysis

and speciation. Expertise in environmental, clinical, pharmaceutical,

chemical, food analysis. Novel methods and chemistries

developed/elucidated. Methods published in peer-reviewed journals.

INSRUMENTATION, METHODS: Spectroscopy, Mass Spectrometry, Optics,

Chromatography: ICP-MS, ICP-OES, AAS, HPLC/ICP-MS, HPLC/MS, HPLC, GC,

GC/MS, FTNIR, process FTIR/NIR/Sensors, UV-VIS, XRF, SEM, FTNMR. Particle

Size Analysis, FTIR/microscopy, UV-VIS, Microbiological, PCR methods, EPA

(SW-846, CLP, Std Methods), FDA (cGMP, ICH, CLIA, CAPA, OOS, OOT, USP,

AOAC), 3A, ASTM, AWS, SEMI methodologies. Human bio fluids (blood, urine).

PROCESS ANALYTICAL CHEMISTRY, CONTROL, ENGINEERING: Hands-on development/

implementation - in-line analysis (FTIR, NIR, non-glass pH sensor).

modeling, validation, calibration, quality systems, data management. In-

situ reactor analysis. Process improvement in consumer products, chemical,

corrosion, semiconductor, food, pharmaceutical, biotech, ultra high

purity/sanitary plant/clean room//construction, metal fabrication,

metallurgy. Co-invented/patented on-line sampling system for process

analysis. Solved polymeric materials issues, developed in-line polymer

analysis methodology. Related process analysis to properties.

CUSTOMER FOCUS: Hands-on product/method development, product formulations

(color, flavor, fragrance, functionality, cost)/synthesis (inks, dyes,

color, drugs, absorbents), scale up, manufacturing, and analytical support.

Synthesis and food experience. Technical support to sales/marketing and

customer contact and interactions. Complex large and small customer problem

solving.

QUALITY: Strategic Planning, Balanced Score Card/Metrics, Continuous

Process Improvement, Army Performance Assessment, Quality Systems, ISO 9000

internal auditor, Baldrige assessor, QA/QC, Automation, SPC, 3A Sanitary,

EPA (SW-846, CLP, Std Methods), FDA (cGMP, ICH, CLIA, CAPA, OOS, OOT, USP,

AOAC), 3A, ISO17025, LQMP/LQPC, DOE, Tech Transfer, HSEEP, ASW Weld

Inspector.

SUPERVISION, TRAINING, COMMUNICATION: Leading multidisciplinary scientists,

engineers, technicians, and field teams. Training program development,

domestic/international delivery to customers and staff. Mentoring junior

technical staff. Customer-focus, applications satisfaction, technical

support for sales, marketing. Developed/delivered 45 courses,

presentations, competitive analyses publications, and publications/posters.

Former trade publication associate editor.

ENVIRONMENTAL, TREATY COMPLIANCE: Chemical weapons, homeland security, OPCW

Treaty, compliance (US Army), chemical & bio agent detection, disposal,

environmental analysis.

EDUCATION

Ph.D. in Chemistry, Texas A&M University

B.S. in Chemistry (ACS certified), University of San Francisco

USMC Command and General Staff College, Marine Corps Institute

Awards

Outstanding Achievement Award, Battelle, 2012

Team Outstanding Achievement Award Nomination, Battelle, 2009

Outstanding Performance Award, Battelle, 2005

Professional Experience

Legis Consultancy, Inc, Atlanta, GA

2012-Present

Chief Scientist

As the Chief Scientist, roles include generating scientific data,

information, interpretation, and guidance for team members and clients.

Preparation of papers, publications, presentations for team and clients.

SME for glove boxes/enclosures/process analysis and instrumentation for

chemical, pharmaceutical, environmental, and nuclear applications.

Experienced in USACE and USDoE projects.

Battelle 2002-

2012

Chemical Demilitarization Plant Operations-Tootle Facility/US Army,

Stockton, UT.

Senior Research Scientist

2008-2012

Promoted from Research to Principle, then to Senior. Functioning as Chief

Scientist and supervised technical oversight and rugged analytical methods

development for agent detection in air, water, soil, construction and waste

materials for plant operations. Novel organoarsenic chemistry discovered.

Developed/upgraded/implemented cutting edge analytical instrumentation;

airborne agent methods; and training for SPE-LC/ICP-MS and SPE-LC/MS

detection of Lewisite, saving major instrumentation and infrastructure

expenses conservatively estimated at in excess of $1MM. Rescued/ensured

$100MM treaty bonus. Solved low agent recoveries issues from absorbent

stripping by hot stack air through the use of cool dilution air, saving in

excess of $500K. Led development team for adsorbent tube cleaning/reuse

savings estimated at $3MM. Interacted with vendor to correct software

problem to correctly transfer analysis time/date stamp to database.

Consultation with customers resulted in technical expertise utilized to

develop safe warhead detonator destruction procedures and agent container

cleaning. Technical supervision of 4 scientists.

Battelle

Centers for Disease Control and Prevention, Atlanta, GA

Research Scientist

2002-2008 Supervised development of rapid, rugged analytical methodology

for chemical weapons metabolites in human biological fluids (blood, urine)

as part of national response to terrorism; methods, and QC/PT testing

materials for cyanide (blood), toxic metals (blood, urine), organoarsenic

speciation, chemical agent and metabolites in bio fluids, food terrorism.

CLIA methods and QA/QC development; development/delivery of training

courses to 47+ state public health labs and governmental agencies (FBI,

EPA); development of QC and proficiency materials; provide consultation/

problem solving expertise to states and government agencies.

Advised/trained US Army in ICP-MS/organoarsenic agent

detection/methodology/procedures for OPCW Treaty Compliance proficiency

testing ("A" in 2008). CDC Chem/Rad Preparedness Goals Team member.

SSS Company/Pfeiffer Pharmaceuticals, Atlanta, GA

Manager, R&D & Analytical Chemistry

2002-2002 Supervised all laboratory (analytical and microbiological) and

quality functions, lab compliance to cGMP, GLP and FDA quality standards

and regulations, CAPA/OOS investigation, FDA and quality documentation

(SOP, OOS), Drug product/process development/improvement, method and

process validation (IQ, OQ, PQ), and personnel training. Formulated sugar-

and PSE-free cold/flu OTC drug products. Managing up to five scientists.

Medical Packaging Technologies, Inc., Doraville, GA

2000-2002

Quality Manager

Supervised all laboratory (analytical and microbiological) and quality

functions; developed/upgraded/ implemented QA/QC plans, procedures;

compliance to cGMP and FDA quality standards and regulations; CAPA/OOS

investigations; facilitating solutions to customer application problems;

all FDA and quality documentation (QSR, SOP); training programs; personnel

training; product/process development /improvement/validation. Managed

Class 1 recall/FDA inspections. Resolved baby wipe quality issues

(strength/weave issues). Formulated antimicrobial mouth rinse, tooth gel,

barrier cream, ointments, shampoos and body baths, lubricating jelly.

Improved skin care product (extended shelf life). Improved OTC

manufacturing process, improved API consistency/profitability/ reliability.

Re-engineered/deployed improved DI Water System to achieve product quality

and safety. Color formulations for products. Customer interaction. Managing

four scientists.

Soil and Environmental Testing Services, Inc., Atlanta, GA

1999-2000

Head Chemist,

Supervised all laboratory operations (chromatographic, spectroscopic, wet,

microbiological); timely, accurate, analytical data production, validation,

interpretation, compliance with EPA, CLP protocols; work load scheduling;

QA/QC system development (protocols, SOP); laboratory troubleshooting.

Developed//implemented ICP-OES and other analytical methods, publications

and presentations; business and proposal development/client recruitment;

pricing; Client Project Management and technical consultation. Drove State

of NC accreditation. Managing five scientists.

Purafil, Inc., Doraville, GA

1999-1999

Director of Technical Services

Managed all laboratory operations and modernization; quality control and

systems, process control and improvement; technical support to

sales and marketing; facilitating solutions to customer application

problems; product development (sensors, chemical air filtration media

research and formulations); technical publications and presentations,

strategic plan, indoor air quality applications, airborne chemical

filtration, corrosion prevention and issues, odor, exhaust gases,

competitor product assessments. Developed a low cost prototype chemical

filtration media life optical sensor, implemented chemical waste/spill

treatment for environmental regulatory compliance, resolved patent issues.

Potential $350,000+/year. Developed/ upgraded/implemented QA/QC plans,

procedures, analytical instrumentation, SPC tracking,

calibration/validation/maintenance, and personnel training. Supervising

four scientists.

North Creek Analytical, Inc., Beaverton, OR

Chemist,

1998-

1999 Supervised timely, accurate, and precise analysis of environmental

samples for metals by ICP, Method development, client recruitment, and

technical consultation. QA/QC protocols and testing validation.

Fullman Co., Portland, OR

Manager of Quality Assurance/Control

1996-1998

Managed all QA/QC phases of UHP piping mechanical installation, welder

certification, welding, weld/leak testing, clean room operations.

Developed/upgraded/implemented QA/QC plans, procedures, analytical

instrumentation, manuals for contamination control, analysis, NDE, welding,

clean room certifications/ operations, UHP systems. Supervising customer

interaction/issue resolution, training, international responsibilities.

Resolved major quality issues at a construction site in Thailand, and

corrosion and metallurgical issues for customers. Managing a team of 5

QA/QC personnel.

KVB/Analect, Irvine, CA

Senior Process Applications Chemist

1993-1996

Responsible for delivery of extensive, experimental assessments for the

feasibility of FTIR and FTNIR

spectroscopic instrumentation for customer (pharmaceutical, food, chemical,

polymers) process and laboratory analytical applications. Development of

system specifications to meet customer analysis requirements; calibration,

statistical and computer modeling, validation, programming, and

documentation of customer systems; develop, perform on-site application

studies; participate in product development teams. Process analysis

applications: plastic/polymer/melt additives and components, in-situ

gas/liquid reactor analysis, dye/ink synthesis in-situ reaction monitoring,

sugar substitutes/acids in consumer products, pharmaceutical, medical and

toxicological applications, air quality monitoring, cGMP cleaning study.

Related process analysis to properties.(estimated $800M-$1MM).

Developed/delivered two calibrated/validated FTIR process analyzers for

major chemical manufacturers ($350M). Lead implementation team for

automated biological fermentation control (FTIR) at pilot/ production

plants (estimated savings of $300,000 per site). HAZMAT and ERT

responsibilities. Developed/delivered Process Analytical FTIR Training

Course for domestic/international customers, lab/plant chemists and

personnel.

Military Experience

Georgia Department of Defense/Strategic Management Office, Clay Nat'l Guard

Center, Marietta, GA

Lieutenant Colonel (P)/ACoS-G5, Georgia State Defense Force

2002-Present

Supervising Strategic Planning/Balanced Score Card/CPI; assistance to GA NG

J5 and GAANG G5. Joint Planning Group and Defense Support for Civil

Authorities LNO duties; Training, Planning, and Operations and integration

into GAARNG operations. Supervised IET School. Task organized and led a

Field Battle Staff during Hurricanes Katrina/Rita mobilization. Formerly,

Deputy Commander, Engineer Corp/Maryland Defense Force/Maryland Defense

Department. ISR inspections. Successfully completed USMC Advance

Amphibious Warfare Course and USMC Command and General Staff College. Army

Center of Organizational Excellence- Baldrige Self-Assessment. HSEEP,

strategic planning, continuous process improvement, US Army Risk Assessment

& Management. Supervising a staff of ten soldiers.

AFFILIATIONS

American Chemical Society, American Society for Mass Spectroscopy, American

Society for Quality, Society for Applied Spectroscopy, Knights of Columbus,

Military Officers Association of America..

Publications, Patents, Training, Prior Food Industry Experience and

References available upon request.

Contact this candidate