Manufacturing Quality Control

David H. Wilkerson

Email: ***************@*****.***

mobile 765-***-****, alternate 765-***-****

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

Martinsville, IN 46151

Email: ***************@*****.***

JOB OBJECTIVE

Quality position within a company specializing in manufacturing and/or

working with analytical testing instrumentation.

QUALIFICATIONS OVERVIEW

. Pharmaceutical research scientist with more than seven years total

laboratory experience and multiple qualifications in analytical and

pharmaceutical/cosmetic research, data collection/analyses and project

management.

. Experience in pharmaceutical R&D/QC testing and equipment: High

performance liquid chromatography (Waters HPLC with Empower software),

Gas chromatography (GC), Dissolution analysis, UV/Vis spectroscopy,

Programming Agilent and ChemStation software, Microtiter plating and

using multiple-head dispensers (ELISA), Micron/Sub-micron particle sizing

by laser diffraction (with Zeta potential analysis), pH/Conductivity

analysis, Endotoxin analysis by turbidimetric method, Total organic

carbon analysis, Liquid particle counting analysis (Hiac/Royco),

Automated potentiometric and manual end-point titrimetry,

Coulometric/Karl Fischer moisture analysis, Osmometry, Viscosity analysis

(Brookfield), Density analysis (Mettler Toledo DE-40), Weighing delicate

chemical samples, Raw material and finished product release testing,

Determination of the physicochemical properties of drug substances.

. Experience in pharmaceutical microbiological testing and equipment:

Sterility testing per current USP guidelines on sterile drug products

using Isolation technology (half-suit isolator), Sterilizing and creating

agar plates, Gram staining for microbial identification, Isolating

various organisms for streak plating, Microscopic identification of

pathogenic organisms, Environmental monitoring for detection of viable

organisms in clean rooms using contact plates and air samplers.

. Extensive experience in composing various scientific research

documents:

.. Technical reports for multiple experiments

.. Standard operating procedures for laboratory and manufacturing

equipment

.. Quality control methods and protocols for experiments and stability

studies

.. IQ/OQ/PQ records for laboratory and manufacturing equipment

.. Master batch records in Phase I, II, III drug manufacturing for

R&D, GLP, GMP, and EU regulations

. Substantial experience in the manufacturing of drug products:

.. Solid and liquid oral dosage forms

.. Parenteral sterile dosage forms, including lyophilizations

.. Drug-excipient interactions

.. Formulation optimization and process development/validation

.. Controlled release systems, emulsions, micro-encapsulations,

vaccines and transdermal drug products

.. Manufacturing multiple drug products for Phase I, II, III studies,

under cGMP US/EU compliance

. Proficient in the use of multiple applications (e.g. MS Office) and

programming languages (e.g. C

. Comfortable and experienced in working with multi-functional research

teams.

EDUCATION: B.G.S. in Biology & Computer Applications, 12/2005

Ball State University, Muncie, Indiana

EXPERIENCE: Microbiologist, 02/2012 - 09/2012

Eli Lilly & Company, 1555 S. Harding St, Indianapolis, IN 46221

. Employment through contract with Volt Workforce Solutions, 1099

N. Meridian St., Indianapolis, IN 46204.

. Performed analytical testing and method development on various

drug products.

. Assisted in sterility testing per current USP guidelines using

half-suit isolators.

. Performed dye ingress testing on various drug products per

company methods.

Senior Scientist, 08/2007 - 01/2012

KP Pharmaceutical Technology Inc. 1212 W. Rappel Ave., Bloomington,

IN 47404

. Performed analytical testing and method development on various

drug products.

. Assisted in developing/manufacturing all types of drug dosage

forms.

. Pre-formulation studies, determination of physicochemical

properties and dosage form development of drug substances.

Laboratory Technician, 08/2006 - 10/2006

Micronutrients, Inc. 1550 Research Way, Indianapolis, IN 46231

. Performed daily potentiometric titrations on multiple copper

solutions for Chloride, Phosphate, Sodium, and Cupric ion-

concentrations.

. Recorded material characterization of company product by

microscopy.

. Experience working in a fast-paced laboratory environment.

Computer Laboratory Assistant, 10/2003 - 12/2003

University Computer Labs, Muncie, Indiana

. Provided technical support in multiple applications for

students.

. Assisted in development of networking techniques.

. Conducted technical research on the university databases.

. Performed maintenance and organization of laboratory computers.

ACTIVITIES: . Fitness Club Member, 2005-Present

. Scuba Certification, 1998-Present

REFERENCES: References will be provided upon request.

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