ALPESH PATEL

**** **** ****, *** # ****

Columbia, SC 29223

215-***-****

abwv4b@r.postjobfree.com

Analytical Chemist

Analytical Scientist with more than 15 years of hands-on industry experience

in analytical laboratories at some of the nation's leading pharmaceutical

companies. Proven expertise in R & D processes, quality control, and the

ability to lead cross functional and cross company teams to achieve focused

results. Expert at implementing and revising analytical methodologies,

managing test results, performing testing and preparing documentation to

ensure regulatory compliance. Knowledgeable in a range of analytical

equipments and techniques to conduct research testing such as HPLC, UPLC,

UV/VIS, Dissolution, AA, TLC, FT-IR, TOC, DSC, Colorimeter, Particle Counter

(HIAC), GC, wet and physical testing. Feature in-depth knowledge of USP, EP,

BP procedures relating to chromatographic analysis and other test methods.

Knowledgeable in separation theories. Skilled in troubleshooting, performing

instrument calibration and maintenance, and providing training support to

analysts. Excellent working knowledge of FDA regulations, ICH guidelines, and

CMC Module 3 documents used in ANDA submissions. Recognized for excellent

management and training of subordinate chemists. Known to solve problems, make

quick and accurate decisions, and brainstorm innovative solutions. Able to

work under minimal supervision and across multidisciplinary teams. Strong

technical knowledge and outstanding communication skills. Skilled at writing

SOPs and IOPs for laboratory equipment. Highly accomplished at coordinating

multiple tasks and meeting tight deadlines. Flexible, self-directed, client

and team-oriented leader.

areas of strength and expertise

Development Validation Laboratory Instrumentation Laboratory Equipment

Method Transfer Services Qualification Process Design &

Vendor Qualification Process Optimization

Technical Writing Laboratory Design

PROFESSIONAL EXPERIENCE

The Ritedose Corporation, Columbia, SC 2010 to Present

Senior Analytical Chemist (Product Development Group)

Serve as a Senior Analytical Chemist for The Ritedose Corporation, a leader

in blow-fill-seal (BFS) contract manufacturing of small fill volume

pharmaceutical unit dose sterile and non-sterile liquids. Prepare, review,

and approve protocols and reports for analytical method validation,

cleaning validation, process validation, equipment qualification, and

stability. Perform method transfer from customers (skilled in six

analytical method transfers). Design, develop, and implement products and

batch records. Perform technical transfer, process development, scale up,

and manufacture of pre-clinical and NDA registration batches.

Key Accomplishments:

. Establish appropriate specifications for drug products, excipient,

components, methods, and sterility

. Developed weight loss method for small volume product (Ophthalmic Soln

& Otic Soln)

. Assess process changes for impact on finished drug product

. Provide leachable and extractable testing support for packaging

component (Resin, Foil)

. Apply aerodynamic particle size characteristics using cascade

impactors

. Involved in process development activities related to the

manufacturing of stability and trial batches

. Work with internal and external experts and the customer to develop

product specifications, testing requirements, and process descriptions

. Actively pursued continuous education and participated in seminars and

group discussions

TEVA Pharmaceutical USA, Sellersville, PA 2001 to 2009

Senior Chemist (Analytical R&D Group)

Served as Senior Chemist for the largest generic manufacturing

pharmaceutical company in the country of affordable solid and semi-solid

medications including a wide variety of therapeutic and

dermatologic options to respiratory and women's health. Responsibilities

included developing and validating HPLC and UV methods for assay, related

compounds, content uniformity, dissolution, and cleaning validation.

Provide analytical data for new formulations. Perform excipient

compatibility studies and comparative dissolution studies to facilitate the

formulation pathway. Develop and improve multiple dissolution methods for a

complex extended release suspension using USP apparatus #2 (paddles) and

apparatus #4 (flow through cell) at different pH levels.

Key Accomplishments:

. Responsible for qualifying primary and secondary in-house reference

standards

. Drafted SOP's, laboratory procedures, certificates of analyses, method

validation protocol, reports, QOS, and related CMC documents

. Served as product development analytical support for TAG group

(technology application group)

. Direct, coordinate, and advise personnel in test procedures for

analyzing components and physical properties of material and products

. Collaborated with multiple external departments in order to facilitate

formulation development, expedite the submission process, and transfer

analytical methods to various TEVA laboratories

. Expert at coordinating the analytical workload to meet critical

milestones

. Feature practical knowledge of Empower and Millennium software for

data acquisition and reporting

. Performed peer review of analytical notebooks and reports

Bristol Myers Squibb Co., Inc., New Brunswick 2000 to 2001

Assistant Research Scientist (PRI - AR&D Group) Temporary

Assumed the responsibility of developing and validating dissolution and

HPLC methods for new drug products.

Key Accomplishments:

. Tapped to provide analytical support for stability studies

. Recognized for performing dissolution and HPLC testing of comparator

drugs and comparing the data with BMS formulation to achieve optimal

results

. Mastered the use of ADS and SQL LIMS for result calculation and

reporting

Geneva Pharmaceuticals Technology, New Jersey 1998 to 2000

Chemist

Responsible for the analysis of raw materials and solid dosage forms using

HPLC. Studied effect of various methods of processing, preserving, and

packaging on composition and properties of drugs. Responsible for

calibration of laboratory equipment on periodic basis.

Key Accomplishments:

. Developed new analytical techniques for the analysis of drug products

. Developed expertise in UV-VIS, GC, FTIR, TGA, DSC, TOC, Conductometer,

Polarogram, and KF Titrator

. Acquired knowledge of cGMP, OSHA, FDA, and USP/EP requirements of raw

materials

. Featured practical knowledge of Turbochrom & HP ChemStation for data

acquisition and reporting

. Responsible for method validation of solid dosage forms using official

monograph

. Responsible for writing monograph and SOP's for laboratory equipment

Glaxo India LTD, India 1995 to 1997

Junior Chemist

Responsible for raw material analysis using UV-VIS, FTIR, KF titration, TLC

and general wet chemistry techniques. Responsible for preparation of

standards and reagents for wet chemical analysis. Knowledge of cGMP and FDA

regulation. Reviewed analytical reports for other chemists.

EDUCATION & TRAINING

Master of Science, Polymer & Physical Chemistry, SP University, India

Bachelor of Science, Analytical Chemistry, SP University, India

Certifications include:

TEVA's Advanced Team Member Certification Coach Certification program

LEADERSHIP SKILLS

USP Reference Standard Team Member (2007 - 2010) Project Leader

(Ophthalmic Solution)

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