Experience Analytical Development and Method Validation under GLP/GMP

Proma Phengsy

** ******* **. *******, **. *****

Work: 973-***-****

E-mail: ********@*****.***

SUMMARY:

. Willing to re-locate, Authorized to work in this country for any

employer.

. 12 years of analytical experience under GLP and GMP regulations.

. Develop and optimize HPLC / Dissolution methods for qualitative and

quantitative tests, establish validation protocols, perform method

validations / write validation reports in accordance with SOP/

GLP/cGMP regulations. Conduct routine analytical tests for release and

stability studies.

. Investigation of unexpected analytical results - ensure that

analytical results are consistent with theoretical results or out

of specification limits or out of pre-established trend.

. Purchase /write Coulometric Karl Fischer Titrator SOP and train

department members.

. Familiar with USP/NF and ICH Guidelines; computer literate and

experience with LIMS.

. Operated instruments - HPLC/Empower2, Fiber-Optic/UV-VIS dissolution

online system, Agilent 8453 UV-VIS dissolution online system, Waters

Alliance Dissolution System, Coulometric Karl Fischer, GC-FID, Ft-IR,

DSC / TGA, Particle Size Distribution (Malvern), Buchi Mini Spray

Dryer B-290, Microscopy.

. Identification and isolation of impurities in drug substance using

Preparative HPLC.

. Excipient identification tests for clinical manufacturing.

. Excellent skills in teamwork and collaborations and ability to

perform multi-task.

. Interface experience with QA GMP/GLP and processing chemistry

teams.

. Qualification, maintenance and calibration of instruments; method

transfer between departments.

. Drug substance and drug product specification preparations;

sampling API /testing plans.

. Cross-working with pre-formulation and formulation teams.

EDUCATION:

2001, MS in Chemistry @ California State University, Northridge (CSUN)

Thesis: Ruthenium Based Catalysts For Base Assisted Alcohol Oxidation

Reactions

Adviser: Prof. Eric Kelson, Department of Chemistry and Biochemistry

(http://www.csun.edu)

1997, BA in Chemistry @ University of California, Santa Cruz (UCSC)

Senior Thesis: The Elusive Delta-9-THC and Its Active Metabolites

EXPERIENCE:

2009 - Current (site closing)

Senior Research Associate, Pharmaceutical Analytical and R & D @ Roche

Nutley, New Jersey.

Essential duties and responsibilities include, but are not limited to:

. Under GLP and GMP, develop/optimize dissolution method for qualitative

and quantitative tests of formulations for GLP and Clinical uses, and

prototype formulation screening.

. Perform method validations and write the reports in compliance with

SOPs and cGMP regulations.

. Compile and bridge the data among the teams.

. Personal goal - set up Fiber-Optic with Apparatus II instruments to

develop an in-vitro dissolution model to simulate the transfer of

poorly soluble weak base drugs out of the stomach and into the

intestine. This model is intended to provide in-vitro

characterization of the solubilization and precipitation phenomenon.

The developed in-vitro model will aid in providing better

predictability of the in-vivo behavior of poorly soluble weak bases

and its impact on oral drug absorption.

2004 - 2009 (site closure and relocated to Roche Nutley)

Research Associate II, Pharmaceutics Department @ Roche Palo Alto,

California.

Essential duties and responsibilities include, but are not limited to:

. Develop / optimize HPLC method for qualitative and quantitative tests

(e.g. identity, assay, purity, impurity content, chiral purity,

residual content of sample, generic vehicle, benzyl alcohol,

homogeneity) of drug substance and drug product for Toxicology and

Clinical studies under GLP and cGMP.

. Develop / optimize dissolution method for qualitative and quantitative

tests of formulations for GLP and Clinical uses, and prototype

formulation screening.

. Establish validation protocol, perform method validation / write

report in accordance with SOP/ GLP/cGMP regulations.

. Establish specification limits for drug substance and drug product in

accordance with SOP

. Prepare stability protocols and set-up the stability studies of drug

substance, drug product and generic vehicle.

. Responsible to test the raw materials for clinical manufacture, set-up

specification limits, and method development as needed.

. Responsible to conduct the initial released and stability tests of the

drug substance, drug product and generic vehicle under GLP and cGMP

regulations.

. Analyze the toxicology samples for release and potency confirmation

for GLP toxicology studies. And prepare technical reports, summaries,

protocols, quantitative analyses and coordinate the GLP QA for

auditing.

. Write the SOP and train the department members.

. Analytical support the pre-formulation / formulation teams.

. Compile and bridge the data among the teams / present and discuss

experiment results within department and project team.

. Preventive Maintenance and Performance Qualification of HPLC and

Coulometric Karl Fischer and Logbooks in compliance with governing

regulations.

2001 - 2004 (moved to Roche Palo Alto)

Analytical Chemist II, R & D Department @ Impax Laboratories, Inc.

Hayward, California. Oct. 2001 - Oct. 2004 (http://www.impaxlabs.com)

Essential duties and responsibilities include, but are not limited to:

. Under cGMP, develop / modify HPLC and Dissolution methods for

qualitative and quantitative tests for experimental formulations and

finished products of small molecules. Perform method validations and

write the reports in compliance with SOPs and cGMP regulations.

. Conduct routine analytical tests of finished products for release and

stability studies in compliance with SOPs and cGMP regulations.

AWARD:

. CMC Award 2006 - for displaying exemplary teamwork and contributing a

positive attitude in support of site programs at Roche Palo Alto,

Pharmaceutics Department.

PUBLICATIONS:

1. Kelson, Eric; Phengsy, Proma; "kinetic study of 2-propanol and benzyl

alcohol oxidation by alkaline hexacyanoferrate(III) catalyzed by a

terpyridyl ruthenium complex," Int J Chem Kinet, 2000, (32), 760 -

770.

2. Kelson, Eric; Phengsy, Proma; "synthesis and structure of a

ruthenium(II) complex incorporating kN bound 2-pyridonato ligands; a

new catalytic system for transfer hydrogenation of ketones," J. Chem.

Soc., Dalton Trans., 2000, (22), 4023 - 4024.

3. Kelson, Eric; Phengsy, Proma; Arif, Atta; "A chloro (2-

pyridinecarboxaldehyde) (2,2':6',2"-terpyridine)-ruthenium(II)

complex," Acta. Crystallographica Section C, 2001, C57, 517 - 519.

PROFESSIONAL ORGANIZATIONS:

1. April 2001, 221st American Chemical Society @ San Diego, CA

2. April 2001, Sigma Xi presentation @ CSUN

3. April 2001, Sigma Xi presentation @ CSUN

4. Nov. 2000, 5th Annual Student Research & Creative Works Symposium @

CSUN

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