Vidhi Patel

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

Souderton, PA****4

267-***-****

acbb3k@r.postjobfree.com

SUMMARY OF SKILLS:

. Great work ethics in adherence to GMP/GLP guidelines, FDA regulations

and company policies.

. Skilled in analytical chemistry techniques with significant knowledge

regarding Dissolution, Content and Blend Uniformity, Assay, and

Impurity testing of solid and liquid dosage form

. Experienced in analysis and operation various analytical

instrumentation such as HPLC, UV-VIS, GC, FTIR, Dissolution Apparatus,

KF, Horiba particle size detector.

. Proficient user of Empower, LIMS (Labware and Beckman), Turbo chrom,

Microsoft Office applications.

. Reviewed activities for approval of instrument qualification (IQ / OQ

/ PQ)

. Effective communication, project management, technical writing and

computer skills.

. Highly motivated, adaptable and trainable; able to quickly learn and

apply complex technical concepts.

WORK EXPERIENCE:

MCNEIL CONSUMER HEALTHCARE, R&D Senior Analyst (contract)

Feb 05 -- Present

Accomplishments:

. Accepted a challenging role in sample management group to receiving,

logging in LIMS database as per applicable study protocols, storing

and tracking of R&D samples.

. Developed IQ/OQ protocols and reports of various instruments as per

the cGMP requirements.

. Assisted in analytical method transfer for drug analysis using HPLC.

. Trained new analysts on a wide variety of methods and instrumentation.

Responsibilities:

. Deliver timely results through detailed project management and focus

to analytical issues, at the same time ensuring accuracy and

consistency.

. Develop, modify and validate analytical methods to support the

formulations, production intermediates and final products using

various instrumental techniques.

. Stability and release testing of solid dosage forms (extended and

immediate release tablets, gel caps, chewable) and suspensions/liquids

mainly using HPLC and dissolution.

. Perform physical tests such as density, hardness, pH, particle size,

moisture content by KF and viscosity.

. Document all experiments and results in a laboratory notebook in a

technically accurate and timely manner according to cGMP guidelines

and in-house procedures.

. Investigate out-of-trend and out-of-specification results.

. Write technical papers, protocols and validation reports.

. Review laboratory notebooks and validate data in LIMS-Fusion.

. Ship samples and maintain data for outsourced stability studies.

WYETH PHARMACEUTICALS, QC chemist Jun

04 - Sep 04

Accomplishments:

. Gained knowledge and experience working in a regulated GMP and GLP.

. Instrument maintenance and troubleshooting

Responsibilities:

. Analyzed raw material, in-process samples, finished products and

stability samples.

. Performed computer analysis of chromatographic results and utilized

LIMS to report results.

. Maintained a laboratory notebook in accordance with SOP's.

. Record, interpret and evaluated the technical data.

NUCLEIC ACID FACILITY AT THE UNIVERSITY OF PENN, Research Specialist

May 03 - May 04

. Synthesized and prepared unmodified and modified oligonucleotides for

biological research.

. Purified oligonucleotides by HPLC and analyzed by CE.

. Performed administrative functions such as data processing of

orders, keeping track of facility inventory, filing, billing and

customer service.

EDUCATION:

University of the Sciences in Philadelphia, Philadelphia, PA

Graduated in May 03

Bachelor of Science in Pharmaceutical Chemistry [pic][pic]

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