Larry D. Butler

**** ******* **.

Mableton, GA. *0126

Cellular: 203-***-****

acpnus@r.postjobfree.com

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SUMMARY OF QUALIFICATIONS

Performance-driven with a wealth of management and laboratory experience, I am one, who has demonstrated expertise in eliciting performance improvement through respect, and by being a hands-on leader known for open and upfront communication. I have shown a consistent ability to motivate teams to achieve exceptional results by using solution-oriented and flexible approaches in problem solving. I am valued for the ability to plan for and achieve long-term business success. My stellar record of accomplishment includes:

• Maximizing profitability through effective leadership, team-building training, and one-on-one team building.

• Re-engineering certain processes to improve productivity and to reduce operation costs.

• Orchestrated performance turnaround in various locations through re-writing policy (SOP), and through training.

• Developing customer-driven operational solutions in order to win customer confidence in departmental procedures.

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PROFESSIONAL EXPERIENCE

For the past 17 years, I have been working for Watson Pharmaceuticals in the capacity of Manager at the New York site and Supervisor at the Florida site. At both site I carried out the day to day routine of a middle size laboratory. Alone with this function I also carried out compliance audits for the laboratory as well as other departments for cGMP compliance and for FDA, EPA and OSHA inspections. I have performed outside audits and performance evaluations on equipment and personnel.

I also have done consulting for various companies during this same time span, where I developed laboratory systems or processes to enhance laboratory performance. My skills are multi-faceted, whether to write documentation, train personnel in various techniques or enhancing the processes of testing.

This brief resume does not reflect the entire summary of my professional experiences, such as those with Boots Pharmaceutical and Central Laboratory. This information is available upon request.

Leadership and Professional Excellence

2008-May 2009

WATSON PHARMACEUTICAL (Florida Site)

Supervise and schedule a staff of 12 scientists in finish goods, stability, complaint samples, raw materials and method transfers. Responsibilities were similar to those in Carmel, NY but rather than managing a team which included supervisors, I directly supervised the day to day testing of goods produced at the Davie, Florida site.

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1992-2008

WATSON PHARMACEUTICALS (New York Site)

(Manufacturer solid dose pharmaceuticals)

MANAGER OF LABORATORY OPERATIONS

Manager of the Laboratory Training department, my responsibilities included training new and existing personnel on laboratory procedures, SOP, GTP, and other official documents pertaining to the Watson guidelines.

I managed a staff of 23 direct reports consisting of three supervisors, sixteen scientists performing finish product and raw material testing and four trainers. The training department is responsible for training all laboratory personnel on technical and non-technical documents.

Wrote and Implemented, Standard Operating Procedures (SOP) and other official documents (i.e., GTP's and SAF policies).

Implemented laboratory Safety Programs that consist of safety audits, inspections and the justification of lost time during accident. This program is instrumental in answering OSHA and EPA concerns but more important changing departmental behavior among the personnel.

I provided technical and non-technical training for all personnel. Training includes HPLC, GC, wet chemistry and cGMP policies regarding to departmental SOP’s.

Perform compliance audits for the preparation of governmental inspections (cGMP, FDA, EPA or OSHA). The audits were presented as parts of a CAPA for the entire company to view and direct to the outcome. The regulations focus on 21CFR part 210 and 21l pertaining to an aseptic and sterile environment. The outcome for this audit were to provide more training to all personnel so they are more informed on cGMP proceeding.

Developed and maintained a certification of all laboratory employees. This program is vital for addressing any FDA related issues and is used during the investigation process with evaluation procedures, equipment, and personnel.

Developed a Control Center to control the workflow, and purchasing of laboratory consumable equipment. This improved the tracking, workflow and purchasing of consumable laboratory equipment which resulted in a reduction in operating costs not only for the laboratory, but the entire organization as well.

Maintained and controlled the laboratory inventory in order to reduce costs and operate the laboratory more efficiently.

I assisted with Federal Regulatory Agency (i.e., FDA, EPA, and OSHA) visits, answering questions regarding the operation of the laboratory.

Investigate and troubleshoot test and procedures -which have been instrumental in developing procedures to investigate equipment, procedures, and test methods; as well as address manufacturing and stabilities concerns with test results and the interpretation of this data.

Evaluate personnel on there job performance, plan for their advancement and offer ways of performing duties

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more effective and reduce cost in performing test.

Schedule testing for over a 120 products with different strength with total manpower of 23 scientific and non-scientific personnel and report these find to Quality Director and Planning Committee (PPIC)

Managed the day-to-day operations in dissolution, assay, raw materials, and identification testing for stability, in-process, complaints and production and execute various protocols.

Involved in various validation processes of new, revised and transferred products performed in manufacturing or R&D setting (i.e. method or equipment transfer).

I performed various internal audits. I operated and I am familiar with Laboratory Information Management System (LIMS).

1990-1992

CENTRAL PHARMACEUTICALS, Seymour, IN

Manager of Quality Operations

1981-1990

BOOTS PHARMACEUTICALS, Shreveport, LA

Senior Chemist of Research and Development

ACCOMPLISHMENTS

In 1994, I was instrumental in re-establishing Schein (now Watson) Pharmaceutical laboratory operation by an order of a voluntary Consent Decree. I performed this same duty at the Steris Pharmaceutical facility (sister company) in Arizona by a court ordered Consent Decree. I developed instrumentation in new laboratory processes and procedures in Metrology (IQ/OQ/PQ) program that aided in re-establishing this Laboratory.

At Watson, I instituted a multi-site Training and Certification Program at Watson, where required employees train and become certified in testing and instrumental procedures.

Instituted an Investigation/Troubleshooting process to address issues in testing and developed a format to document those findings.

Instrumental and developed a workstation in order to improve efficiency and reduce cost of testing.

Instituted a Safety Program to investigate and track accidents.

Developed a Training Program on cGMP and GLP.

Developed Hazard Assessment plan for the laboratory.

Developed a training database to incorporate official documents (i.e., SOP, SAF, GTP and FMC) into a training matrix that resulted in easier flow.

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Wrote and implemented executed protocols at the Phoenix site.

Developed a Control Center at the Phoenix site where supplies and samples are accounted and scheduled for testing. The Control Center improved efficiency and reduced costs.

I wrote an array of instrumental SOPs for use at both the Carmel and Phoenix facilities.

Factors that Drive Success

• Instrumentation - Understand the operations of a vast number of instruments used in the pharmaceutical industry, such as GC, HPLC, FTIR etc.

• Troubleshooting and investigating problems that are associated with instrumentation, human error, or method issues.

• Using an array of techniques to communicate with team and individuals.

• Developing Methods and Training Procedures.

• Developing and writing official documents (e.g., SOPs, protocols)

• Implementing Training, Safety related programs.

• Operation various software such as LIMS, CAPA, FoxPro, as well as Windows, etc.

EDUCATION

1981 BS, Chemistry/Louisiana State University

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MEMBERSHIP AFFILIATIONS

Alpha Phi Alpha Fraternity Inc.

Sertoma Club

Member of American Chemical Society

American Analytical Pharmaceutical Association

United Way Fund Raiser

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REFERENCES

Excellent references will be supplied upon request.

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