Charles S. Graham

* *** *. ********* ***. Apt. *

* *********, **, *****

* ****** *****: 269-***-****

* *****: ab84hq@r.postjobfree.com

Objective To obtain the position the pharmaceutical, medical product or food industry.

Education

Western Michigan University, Kalamazoo, MI Graduated Spring 2001

Bachelor of Science

Major: Biomedical Sciences and English

Minor: Chemistry, General Mathematics and Philosophy

Employment

Laboratory Instrumentation Technician, Johnson Controls, Portage, MI 4/30/12-

8/07/12

Duties: Corrective and preventative maintenance of laboratory equipment including HPLC (Agilent, Waters, Beckman,

TSP), GC (Agilent and Waters), scales, balances, filter integrity testers, HERG boxes, pH meters, ovens, vacuum ovens,

microwave digestion ovens, dissolution apparatus, NMR.

Training: Trained on repair and preventative maintenance of a wide variety of equipment.

Analytical Chemist, KIK Custom Products, Elkhart, IN 6/06/11-4/27/12

Duties: Performing chemical analyses on raw materials, batches and finished products using HPLC, GC, FTIR, UV and wet

chemistry techniques. Developing analytical procedures under direction from the Lab Manager. Troubleshooting

instrumentation and methodologies when mechanical or procedural difficulties occur. Validate newly developed methods to

meet GMP procedures under directions of the Manager. Act as a shift leader for the 2nd shift analytical team. Maintenance

and troubleshooting of instrumentation, including Agilent and Beckman HPLC and Agilent GC, as well as Karl-Fisher, pH

meters, balances, refractometers, density meters, UV-VIS, etc.

Training: Familiarity with KIK Custom Products operations and procedures.

Quality Assurance Research Auditor, MPI Research, Mattawan, MI 1/12/10-

11/1/10

Duties: Auditing and making observations on study protocols, in-process laboratory inspections, data, draft and final reports

in regards to adherence to GLP, OECD and/or other foreign regulatory guidelines. Reviewing draft SOPs. Extensive work

with the Immunology department to help improve the quality of their data, protocol templates, and to greatly improve their

relationship with QA.

Training: Further in-depth GLP training and auditing.

Laboratory Manager / Lead Scientist, Newport Scientific, Inc., Irvine, CA 10/03/05-9/15/09

Management Duties: Overseeing all laboratory activities, including sample flow and processing, employee adherence to

laboratory protocols and general laboratory / equipment maintenance. Personnel management (hiring, dismissal, training,

review, promotion and arrangement of work schedules) of 2-3 research associates.

Technical Duties: Development and validation of new analytical methods from writing the protocol through writing the

final reports. Conducting stability studies of new formulations and new experimental compounds, from protocol to final

report. Presenting data to clients and acting as an interface between the owner of the company, the clients and the work done

in the laboratory. Setting up and running formulation comparison studies (doing the formulation work and analyzing each

formulation by HPLC), setting up and running forced degradation studies and analyzing the samples by HPLC using PDA

detection, impurities testing by HPLC, summarizing and presenting data, writing the SOP’s for the laboratory, personally in

charge setting up and maintaining the lab and everything in it, formulation of product to be shipped to external labs for testing,

method development and validation of HPLC methods, automating Empower software through the development of custom

fields, calculations and reports Other analytical testing as needed. Oversaw the setup and implementation of GLP compliance

for the laboratory.

Training: Maintenance of Beckman HPLC systems, Karet32 software, Horiba particle size analyzer, management of

laboratory personnel.

Associate Research Scientist, Pfizer, Kalamazoo, MI 9/06/04 – 9/30/05

Duties: HPLC impurities testing of clinical and analytical stability samples in support of new drug development, serve as

local resource for empower expertise, calibration of HPLC detectors and gradient pumps as needed, work with a committee to

re-write the Unit Guidelines and Record Checking SOP’s, method transfers.

Training: Received more in-depth training in impurities testing using a variety of PerkinElmer, Thermo-Sep, Agilent and

Waters HPLC systems, as well as maintenance and troubleshooting of those systems, on going training in safety and wet

chemistry techniques.

Research Analyst, Kellogg, Battle Creek, MI 8/11/03 – 6/28/04

Duties: Project-based method development, optimization and validation using HPLC and GC. Developed and validated

methods for trans-fat analysis of foods and oils (separately) via acid hydrolysis/ether extraction/methylation sample prep and

HP GC with FID detection, for analysis of a phenolic antioxidant by HPLC with PDA detection and for analysis of

cyclodextrins via HPLC with RI detection.

Training: Maintenance and troubleshooting of Agilent GC systems, Chemstation software. HPLC purity testing and library

matching with a photodiode array. Trained in multiple extraction techniques and sample prep methodology. Validation

methodology and documentation.

QC Analyst, Perrigo, Allegan, MI 2/25/02 – 8/01/03

Duties: HPLC and physical properties testing of multi-active pharmaceutical products, inputting test results into LIMS,

chairman of the Safety Committee held responsible for safety and regulatory compliance of the lab as a whole, member of the

certification team. Method transfers, participation in HPLC method development. Participation in out of specification results

investigations as necessary.

Training: Trained on HPLC (single and multi-active, some impurities testing, method development/transfer,Millenium 32

software use and installation), LIMS, extensive dissolution training, density meter, refractometer, UV-Vis, FTIR, Karl-Fischer,

viscosity, maintenance and troubleshooting of Waters HPLC systems, maintenance of HPLC columns, ERT training. Trained

on multiple procedures and regulatory requirements needed in order to produce second-checked data for release of product.

Ongoing cGMP regulations training and compliance.

Intern – Supplier Quality Management Team, Pharmacia, Portage, MI 4/17/00 –

4/17/01

Duties: Migration of the Approved Supplier Database from Microsoft Access ’97 to VisualBasic, work with IT on computer

validation, set up a database to store and track audit reports, write SOP’s governing the use of this database, train database end

users.

Training: CGMP’s, Corporate SOP’s, Computer Validation, Supplier Audits, became familiar with Oracle SQL.

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