WAYNE R. HEITMANN

*** ******* ****

Grayslake, IL 60030

Home: 847-***-****

Cell: 847-***-****

abgyyj@r.postjobfree.com

Professional Summary

Masters level organic chemist with a proven successful career in the global

pharmaceutical manufacturing industry. Currently a Quality Engineer

experienced in CAPA investigations, Trackwise Exception Report System, SAP

product batch release, specifications and lot tracking. Also experienced in

Quality Compliance Auditing; chemical process technology transfer; process

improvement and troubleshooting for active pharmaceutical ingredients

(APIs) and intermediates; and improving chemical process quality, cost and

safety. Career track includes developing chemical processes from laboratory

through pilot plant and manufacturing scales; daily pharmaceutical

manufacturing process support; and quality compliance auditing of domestic

and international corporate and supplier facilities.

Professional Experience

Abbott labs - Diagnostics Division (Manpower)

Biologist

III/CAPA Investigations

2010-2011

Assisted in the investigations of CAPA exception reports and preparation of

corrective action plans. Performed data mining and database tracking of all

related exception reports, corrective action plans, corrective actions-

preventive actions and effectivity checks. Continued training to become an

approved CAPA investigator. Created new tracking tools to facilitate

quality metrics analyses.

Sigma-Aldrich

Quality Assurance

Associate

2008-2009

Using SAP software, release product batches, monitor inventory, track

laboratory testing and set specifications. Create and process

specifications and other product related updates through the Change/Delete

database (Lotus Notes). Investigate product failures and customer

complaints. Assist the laboratory and manufacturing with product and

process related issues.

Abbott Laboratories

Senior Quality Compliance Auditor 2003-

2007

Audited corporate domestic and international quality systems for compliance

to the appropriate FDA, international and corporate requirements. Planned,

executed and reported the audit results, CAPA and tracked the remediation

of any observations to satisfactory conclusion.

. Minimized overall auditing expenses and time by instituting remote

audits, in which a specific quality documentation system (e.g. Annual

Product Reports) is audited across multiple global sites without

travel.

. Eliminated or prevented sources of particulate contamination by

performing extraneous matter audits of corporate manufacturing

facilities.

. Reduced compliance risks and potential product losses by

investigating and finding the causes of HEPA filter durability failures

in corporate manufacturing facilities.

. Wrote validation protocols and reports covering various diagnostic

test kits for submission to the FDA.

Abbott Laboratories

Senior Development Chemist: Technology Transfer / Outsourcing

1992-2003 Outsourced or transferred chemical process technology for several

APIs and intermediates to Europe and Puerto Rico. Innovated and implemented

process improvements in global facilities.

. Supervised and led a team of engineers and chemists on an API project

which resulted in extension of corporate sales in excess of $1 billion;

90% reduction in API impurities; 90% reduction in chemical waste; 17%

reduction in manufacturing cost; and a critical patent for the

manufacturing process and its key crystal form.

. Retained major manufacturing tax incentives by transferring

intermediates manufacturing technology to a TPM in Puerto Rico.

. Participated in the transfer of an API manufacturing process

to Ireland, resulting in more successful positioning of the product

manufacturing for global supply.

. Improved product quality, cost and third party sales by innovating

and transferring a key intermediate process to a U.K. TPM.

. Increased domestic manufacturing capacity by successfully

transferring key intermediate process technology to a TPM in Germany.

. Participated in the development and implementation of common process

validations, an innovative and cost effective way to satisfactorily meet

certain regulatory validation requirements.

. Innovated and implemented important macrolide antibiotic process

improvements as a process support chemist.

Abbott Laboratories

Senior Development Chemist 1987-

1992

Performed the daily chemical process support of an API and intermediates

facility. Generated improvements in process cost, safety and quality as

well as implementing effective solutions to routine processing problems.

. Contributed significant yield, safety and cost improvements by

providing daily process support for a wide variety of products including

controlled drugs, APIs and intermediates.

. Produced a large cost reduction and increased efficiency by

implementing a reduced charge of a precious metal catalyst in an

intermediate process.

. Generated a 10% increase in product yield and more efficient use of

the other materials and equipment by implementing a manufacturing

process change born from a study of product batch records.

Publications

. U.S. Patent 5,504,207: Process and intermediate for the preparation

of terazosin hydrochloride dihydrate

. U.S. Patent 4,220,801: Process for making 4-aroyl-substituted

phenoxyacetic acids

. U.S. Patent 4,217,282: Process for making N-(2-methyl-1-naphthyl)-

maleimide

. Jack K. Crandall, Wayne R. Heitmann: "Journal of Organic Chemistry,"

Vol. 44, No. 20, pp 3471 - 3474.

. J. Bauer, W. Heitmann, et. al.: "Journal of Pharmaceutical Sciences,"

Volume 95, Issue 4, Pages 917 - 928, Published Online: 21 Feb 2006.

Military

U.S. Army, Specialist 5th Class: Computer Data

Specialist

Education

M.S. Organic Chemistry, Indiana University, Bloomington,

B.S. Chemistry, Valparaiso University, Valparaiso, IN

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