FRED KHODADAD

**** ****** **. ******* *****, IL 60089 acenmx@r.postjobfree.com Tel: 847-***-****

SUMMARY Sr. Analytical Chemist with significant progressive experience:

1. Proficiency in compendial and non-compendial wet and instrumental methods of analysis,

including and not limited to: Karl Fischer, HPLC, GC, UV-VIS, AA, FTIR, Thermal Analysis

(DSC, TGA), TOC, rheology, polarimetry, conductimetry, potentiometry, particle size

analysis and manual and automated dissolution testing.

2. A visionary approach, utilizing new techniques and instruments resulting in simpler and

faster analyses.

3. Fluent in GMP guideline governing analytical methods validation and transfer, stability

studies, laboratory investigations, cleaning studies, instrumentation compliance including

validations, qualifications and calibration with related documentation.

4. Excellent verbal and written communication/documentation skills with effective utilization of

MS Office etc. for generation of documents such as investigation plans, troubleshooting

and various protocols and reports.

5. A highly inventive, multi-disciplinary and teamwork oriented approach has been

instrumental in successfully addressing the analytical needs of the global manufacturing

and R&D developmental activities, formulation and process characterizations and product

improvements and troubleshooting.

6. Proven leadership demonstrated by highly empowered and motivated direct reports.

PROFESSIONAL EXPERIENCE

Sr. Analytical Chemist / Instrumentation Compliance, Watson Actavis Pharmaceuticals

(2004 to Jan 2014), Mount Prospect, IL.

Responsibilities included:

-Alternate Vendor Qualifications through exhaustive comparative physical/chemical testing of

API’s from different vendors and generation of corresponding reports and recommendations in

support of Global Manufacturing.

-Generation of protocols and executing HPLC, GC, UV and dissolution method validations and

transfers as guided by ICH/ FDA and internal guidelines.

-Stability testing on finished pharmaceutical products and generation of Excipients Compatibility

Studies, in support of new and more stable product formulations.

-Development of new test methods and remediation of existing Analytical Methods, mainly HPLC,

and validation and transfer of these methods to QC lab.

-Coordination of Instrumentation Compliance through managing all calibrations, qualifications and

maintenance with the pertinent documentation.

-Designing investigations and trouble-shooting studies in support of OOS results, product

complaints and FDA deficiency letters and generating the corresponding reports.

-Serving other departments for product/process evaluation and optimization and performimg

required chemical/physical testing including chromatographic and spectroscopic methods as well

as Karl Fischer, and other wet methods, thermal analysis (DSC and TGA) and particle size

analysis, employing a variety of instruments such as Camsizer, Malvern Mastersizer 2000 and

Horiba LA900 laser diffraction analyzers, as required by internal customers.

-Generation and regularly revising all instrument-related SOPs of Laboratory Operations, covering

use, calibration, qualification and maintenance.

-Managing lab supply procurement and generation of the monthly P-Card reconciled statements.

Research Chemist/Instrumentation and Validation Specialist, Searle, Monsanto, Pharmacia,

Pfizer (Successive acquisitions-Same location) (1985-2004), Mount Prospect, IL.

Supported Global Manufacturing by:

1. Participation in product/process investigations and marketed product support by providing

analytical testing, analytical method development and validations, and technology and

analytical method transfer services worldwide.

2. Responsible for all aspects of analytical instrumentation compliance, including hands-on

work and coordination of outside vendors.

3. Responsible for Investigation protocol generation, testing and preparation of final report in

support of investigations, marketed product trouble-shooting, FDA Deficiency Letters and

other product/process-related studies

Consultant, Hospira Pharmaceuticals (April-June 2014), Lake Forest, IL.

Participated in analytical compliance remedial work by generating reports that addressed

validation gaps by presenting justifications and/or recommendations to bring the documentation

for the test methods into compliance, as guided by regulatory guidelines and company internal

SOPs.

EDUCATION:

1. BS in Chemistry, Roosevelt University, Chicago, IL.

2. MS, Analytical Chemistry, in progress also at Roosevelt. Completed graduate courses

include: GCMS Techniques, Advanced Organic and Inorganic, Advanced Instrumentation,

Spectrometric Methods of Organic Analysis.

3. Many relevant courses and certifications such as: Analytical Methods, Validations/Transfer,

Instruments Qualification, Calibration and Maintenance, GMP/GLP practices, laboratory

Investigations, Dissolution Method Development, Compendial Method Verifications, High

Purity Water Generation and Testing, and Particle Size Measurement. Certifiates are

available.

OUTSTANDING ACHIEVEMENTS:

1. Implemented a new Laboratory Instrumentation Compliance Quality System in Watson

laboratories, through generation and updating of general and instrument-specific SOPs

and participated in managing all aspects of instrumentation life cycle, with respect with

acquisition, calibration, maintenance and qualifications. Successfully passed 3 FDA

audits with no observations.

2. Impacted Global Manufacturing by comparative evaluation of APIs and excipients,

through exhaustive chemical/physical testing, collaborating with vendors for remedial

action and generating the report and recommendations for sourcing of these materials.

3. Successfully developed and revised HPLC test methods in support of Global

Manufacturing. Introduced novel analytical techniques such as a test method for the

analysis of Total Oxidizing Compounds in a wide range of materials. This method is

systematically used by the company to screen out the excipients with high oxidizing

activity and thereby achieving formulations with minimal oxidative degradation and

increased stability and shelf life.

4. Developed a novel GPC chromatographic technique to perform qualitative and

quantitative analysis on polymers such as Klucel and Ethocel, used as binder and

Sustained Release Agents in solid dosage forms. The above method was used to

measure the extent of fragmentation of the polymers and their relationship to the

dissolution rate. This has been proven to be a valuable screening tool by the company

for selecting ingredients which produce acceptable dissolution rates.

5. Developed many automated dissolution methods using in-line UV-VIS measurement,

replacing methods based on HPLC, thereby reducing the analysis time and cost, while

meeting regulatory requirements.

REFERENCES: Available.

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