Manager Development

SKILLS

Analytical Capabilities:

Method Development and Validation

Developed and validated methods for Soft Gelatin Capsules, API, and

Tablets (Assay, Content Uniformity, Cleaning, In-Process, Dissolution,

Degradation Products and Residual Solvents): Analysis of drug

substances, solid dosage and liquid dosage forms, using HPLC

(Fluorescence, UV, PDA, DAD, RI and LC/MS/MS, GC (FID), TLC, UV, FT-

IR, KF, and thermal analysis (DSC, TGA). Analysis of herbicides and

pesticides in different matrixes using: HPLC (Fluorescence, UV, PDA,

DAD, RI) and GC (FID, ECD, Hall, NPD, headspace and MS). FD&C color

analysis using HPLC and UV. Dissolution method development of low

dosage ( g per capsule) finished product using apparatus 1, 2 and 3

and small volume apparatus using manual and automated and manual

sampling.

Regulations:

GMP/GLP Guidelines

Maintenance and Troubleshooting:

HPLC (DAD, RI, UV, PDA), GC, DSC, LC/MS/MS, MS, TGA and GC (FID, ECD,

Hall, NPD, Headspace and MS)

Computer/Chromatographic Data Systems/operating systems:

Microsoft Office, ChemStation (Agilent Technologies, Inc.), MassHunter

(Software for triple quad from Agilent Technologies, Inc.),

Millenium32/Empower (Waters Corporation), Multichrom and Atlas

(Thermo), DOS, Windows, Linux, Open VMS, Computer validation and

administration of CDS systems.

EXPERIENCE

Banner Pharmacaps - High Point, NC

(June 1996 - March 2013)

Developed and validated HPLC methods for assay, content uniformity, in

process, cleaning, and degradation of API in Soft Gelatin Capsules and

Solflets

Developed and validated GC methods for residue solvents in drug

substance for NDA filing

Released API and raw materials using compendial methods (USP, EP)

Perform stability studies on soft gelatin capsules for filings to FDA

System installation and validation of Multichrom (chromatographic data

system) for R&D and QC

Project management (installation and validation) of Atlas

chromatographic data system on the entire site.

Used as resource to solve analytical issues within individual

departments at Banner

Successfully coordinated and assisted installation and validation of

LC/MS/MS

Successfully transferred in and developed methods using the LC/MS/MS

Method qualifications for methods from other sources.

Performed instrument repair and qualification.

Dupont-Merck/Dupont - Wilmington, DE

(August 1988 - May 1996)

Developed and validated HPLC methods for the determination of various

drug substances in pre IND stage.

Developed and validated robotic methods for the determination of

various drugs in solid dosage forms (tablets)

Developed and validated HPLC methods for assay and degradation of drug

candidates in different solid forms for NDA filing

Developed GC/MS methods for development and validation of residue

solvents in API

Developed and validated GC methods for residue solvents in drug

substance for NDA filing

Perform stability studies on solid dosage forms for filings to FDA.

Trained colleagues on use and operation of thermal analysis and KF

Perform thermal analysis of new drug candidates

Wastex, Inc. - Pottstown, PA

(Oct 1986 - April 1988)

Developed and validated HPLC and GC methods for herbicides, pesticides

and PCB's in various matrixes

Set up environmental residue laboratory to be in GLP compliance

Trained colleagues on use and operation of HPLC and GC

Developred extraction methods for complex sample matrices

Franklin (contract at DuPont Ag Products) - Wilmington, DE

(June 1983 - September 1986)

Developed and validated HPLC methods for herbicides in difference

matrixes for Experimental Use Permits issued by EPA

EDUCATION

Bachelor of Science,

Old Dominion University, Norfolk VA

Math major, chem. minor

Training

GC-short course, DuPont-Merck-Harold McNair of VPI, 1993

Instrumental Analysis, DuPont-Merck/ U of Delaware-Graduate level course,

1993

Electronics, Delaware Technical and Community Collage, 1991-1992

Electricity 1 and 2, Delaware Technical and Community Collage, 1990-1991

Digital Electronics, Delaware Technical and Community Collage, 1991-1992

Thermal Analysis, Dupont, 1989

Thermoanalytical Methods, Center for Professional Advancement,1993

Fundamentals of Dissolution, Vankel, 2001

Multichrom System Manager Training, LabSystems, 1998

Intro to GC-MS, Hewlett Packard, Course H2609A-Staff, 1992

POSTERS

Authors Title Location/Date

S. L. Kintner Thermal System Validation North American

C. L. Umbles Thermal Analysis

Society, 1994

S. L. Kintner Assay for degradation products and esters AAPS, 2001

D. A. Kruep of Ibuprofen

Steven L. Determination of Esters of Naproxen in AAPS, 2002

Kintner Soft Gelatin Capsules

Dale A. Kruep

S. L. Kintner Perilly Alcohol Analysis AAPS, 2003

D. A. Kruep

S. L. Kintner Developing a Dissolution Method for AAPS, 2004

D. Kruep Progesterone Soft Gelatin Capsules

S. L. Kintner Progesterone Assay: An Alternate Approach AAPS, 2005

D. A. Kruep

Abra E. The Development of an Assay method for AAPS, 2007

Birchall the Determination of the Loperamide HCL

S. L. Kintner content in Loperamide/Simethicone Soft

Dale A. Kruep Gelatin Capsules

Abra E. The Development of a Suitable method for AAPS, 2008

Birchall the Determination of Degradation products

Steven L. in Loperamide HCl Soft Gelatin Capsules

Kintner

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