Project Quality

Niketa Patel

Lincoln Park, New Jersey ***** . 201-***-**** .

***********@*****.***

Summary

Highly knowledgeable diversified pharmaceutical professional with more than

ten years of expertise in pharmaceutical R&D sector with a focus in

Analytical Chemistry, Quality, Regulatory compliance, Analytical method

transfers, Quality control, Method development/validation and Laboratory

qualifications.

. Solid knowledge of Good Manufacturing Practices, FDA requirements, Pre-

Approval Inspections, ICH Guidelines and Good Laboratory Practice

(GLP).

. Excellent report writing skills; experience authoring numerous

validation/investigation reports, SOPs, protocols, method

qualification reports, and internal documents.

. Proven skills in method development and validation, writing and

issuing validation reports/protocols, SOP's and laboratory

investigations.

. Industrial experience includes analytical analysis on a variety of

drug substance products with emphasis on strength, purity, content

uniformity and dissolution in a GMP environment.

Technical Skills

Computer Skills: Microsoft Office, Perkin Elmer TotalChrom,

UNIX LIMS, Chemstation, Water's Empower-2 Chromatography Data

Software, Quality by Design, Design of Experiment (DoE), and Dry

Lab.

Instrumental Skills: HPLC, UPLC, UV/VIS Spectrophotometer,

Dissolution Apparatus, pH meter, and Karl Fischer.

Professional Experience

Wyeth Pharmaceutical Inc. /Pfizer Inc., Pearl River, New York 2008-2010

(Pfizer acquired Wyeth in October 2009)

Research Scientist II 2000-Present

. Perform analytical analysis of Stability samples, Process Validation

samples and finished drug product release samples using In-House

methods following SOPs, cGMP, and FDA regulations.

. Coordinated all analytical testing related to high priority projects

Relistor, Lybrel and Rapamune.

. Utilized instruments such as HPLC, LC/MS, UPLC, and UV/Vis to develop

and validate methods.

. Contributed oversight related to compliance, quality, data integrity,

method validation, and technical transfers to research and development

division of Wyeth.

. Designated responsible trainer of analytical methods and experimental

procedures for new staff ensuring highest level of accuracy.

. Audited notebooks and analytical data prior to FDA audits and Pre-

Approval Inspections (PAI) to ensure integrity of information supplied

by research and development and to reconcile data contained in

notebooks with data in LIMS.

. Oversaw implementation of protocols for several new lab instruments,

performing IQ/OQ/PQ while working with metrology and quality staff to

ensure instrumentation was available without delay.

. Coordinated technical transfers of NDA candidates and methods to third-

party laboratories and other Wyeth sites.

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Research Scientist I 2006-2007

. Analytical project leader for new drug candidate under co-development

between Wyeth and business partner.

. Identify critical project issues, recommend and implement courses of

action to expedite project objectives.

. Trained scientists on various analytical methodologies such as

strength, degradation and dissolution methods.

. Function as primary liaison between AQS and other department for

project issues, including the planning and execution of protocols-

specific deliverables and managing data.

. Recognized leader for analytical tech transfers globally to Wyeth

commercial and third party manufacturing sites.

. Develop and validate analytical methods using separation techniques

(HPLC and LC/MS) for Active Pharmaceutical Ingredients (API) and drug

products (solid oral, liquid and parenterals).

. Member of empower tech team, implemented Waters Empower software

package throughout the department, and provided training to staff.

. Provided technical support during FDA audits and Pre-Approval

Inspections (PAI)

Niketa Patel Page Two

Scientist II 2004-2005

. Provided status updates on projects by monitoring Integrated

Management Report (IMR) for the entire Analytical Quality Science

(AQS) department to Director.

. Contributed to development of methods, cleaning validation studies,

SOPs, and other internal documents.

. Perform analytical testing on a variety of dosage forms for women's

health and inflammation drugs following established methods and

standard operating procedures.

. Travel extensively to accomplish business goals eg: North Carolina,

Puerto Rico, Montreal, Italy, Germany and Ireland on numerous

occasions to support woman's health, inflammation, metabolic and

cardiovascular projects.

. Assist supervisor in various administrative activities, reviewing

notebooks, issue necessary reports on time, provided data, trend

analyses etc, for regulatory submissions.

. Strong organization skills with ability to efficiently evaluate,

prioritize and handle multiple and changing priorities and projects.

Scientist I 2001-2003

. Perform analytical release testing on a variety of API, clinical

supply and drug products under cGMPs.

. Review work of other chemists, as assigned to ensure accuracy,

completeness and compliance with departmental SOP's.

. Audited and provided suggestion on the GMP compliance of the

laboratories.

. Perform method development and qualification/validation of analytical

methods under the guidance of experienced colleagues.

. Analyzed samples for potency, degradations and dissolution by HPLC,

UPLC and UV/Vis. Excellent investigative skills involving root cause

of stability problems and solid writing skills to author and submit

required reports for filing.

. Organized and managed lab, maintained necessary records, developed

protocols, designed SOP's and presented data at departmental meetings.

Analytical Chemist 2000-2001

. Develop and validated analytical methods using HPLC, UV-Vis, GC and

titrimetic methods.

. Extensive training on 21CFR part 11 compliance.

. Evaluated existing monograph methods.

. Excellent skills of documentation, technical report writing, direct

inclusion of figures and graphs.

Early Experience

McNeil Specialty Products Co., Div. of Johnson & Johnson, New Brunswick, NJ

1998-2000

Assistant Research Scientist

Education

MBA Iona Hagan School of Business New Rochelle, NY

BS in Chemistry and Biology New Jersey City University, Jersey City, NJ

Certification

Iona Hagan School of Business, New Rochelle, NY

. International Business Certificate

Water Corporation Millford, MA

. Empower-2 Chromatography Data Software Training

. Empower-2 Advanced Topics: Custom Fields and Reports

Achievements

. Patent Application for novel compound - 2007

. Patent Application for novel compound - 2009

. Team of the year Award for European Compliance Initiative Support -

2005

. Team of the year Award for Relistor project - 2006

. Team of the Year Award for Relistor Oral Program (Tablet) - 2007

. Graduated Wyeth Diversity Leadership Development 2 year Program - 2008

. Presented poster at Analytical Quality Science (AQS) Day of Science

Symposium - 2009

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