R & D Director Looking for Scientist position

JIGAR PATEL

***-** **** ***. ***# *C ? Bayside NY - 11361 ? *************@*******.*** ?

832-***-****

OBJECTIVE: A challenging position as a Scientist (Formulation) in

pharmaceutical industry where I can effectively contribute my skills and

experience

TECHNICAL SKILLS:

. More than 4 years of Pharmaceutical formulations experience in OTC and

Prescription Drugs

. Knowledge in creating Documentation, according to cGMP Guideline for

Drug Regulatory

Affairs used to export products in various countries

. Extensively used IIG and Hand book of Excipients to develop an

Innovative and Novel

Drug Delivery System of various conventional moieties

. Experience in Handling and preparing SOP's (Standard Operating

Procedures) of various Equipments like

> Liquids: Jacketed Steam Vessel High speed stirrer, Colloidal Mill

> Solids: fluid bed drier/granulator, multiple punch tablet press

> Semisolids: Sigma Blender, Triple Roller Mill

> Dryers: Spray Dryer, Vacuum Dryer, Tray Dryer

> Sterilizers: Autoclave, Hot air Oven

> Quality Control Equipment: Friability tester, Hardness Tester,

Dissolution & Disintegration test apparatus, HPLC, UV

Spectrophotometer, GC, Brookfield Viscometer, pH meter

. Good understanding of NDA, ANDA, Orange Book, ICH guideline, CFR, Common

Technical Data for filing and Use of Patents and Patent around Design

. Well versed with scale-up and technology transfer process with an

experience of Exhibit Batches conducted successfully as per cGMP

Guidelines in a US-FDA Approved plant

. Experience in development of solid dosage forms

. Knowledge of determining the Mechanism of Drug Release via MS-Excel for

Drug release at a predetermine Rate (Controlled Release)

. Prepared Buffers like Acetate Buffer, Phosphate Buffer, Saline

Phosphate Buffer

. Hands on experience with coating of tablets and pellets with

functional and non-functional

Coating solutions and well versed with coating procedure

PROFESSIONAL EXPERIENCE:

Time Cap Labs, Inc. (January 2012- Present) (OTC Generics company)

Research and Development Director

. Designed and executed formulation experiments

. Learned more about QBD and ICH guidelines

. Developed manufacturing processes for R&D formulations so that the

technical transfer is successful for large scale batches

. Wrote Master formulas, manufacturing procedures, product development

reports and post validation reports

. Coordinated the manufacturing of stability batches

. Reviewed stability protocols, reports and results to finalize

formulation for commercial use

. Provided technical support in the time of Process validation and when

any issue in the compression of commercial batch such as Sticking,

Capping, Laminating and in Coating such as Sticking to pan walls,

Cracking and Twinning

. Coordinated with Quality control Department, Regulatory Affairs,

Quality Assurance, and purchasing and sales department to expedite the

development new products

. Hands on experience with tablets and pellets (beads) coating for

functional and non functional coating solutions.

. Matched colors for various timed or un-timed pellets.

. Mastered Sugar Coating

. Re-formulated enteric or delayed-release coating solutions from

alcoholic to aqueous solutions.

. Learned more about various analytical equipments such as Dissolution

Apparatus, HPLC, IR and Method developments based on USP.

InvaGen Pharmaceuticals Inc. Hauppauge, NY (September 2011- January 2012)

Quality Assurance Associate - Manufacturing

. Performed In-process checks of the qualitative tests such as Weight

variation, Hardness, Thickness, Friability and Disintegration

. Collected samples of various products in Final-mix(Blending) and Finished

Product level and issued them to the QC laboratory to conduct necessary

tests

. Maintained accurate entries and calculations in the Batch Manufacturing

Records

. Assisted the Formulation Scientists in Characterization and validation of

the ANDA batches on the production floor

. Conducted tools assessment for approval or rejection after specified

number of tablets compressed by that tool-set

Wal-Mart Pharmacy, Houston, TX (January 2010 - September 2011)

Registered Pharmacy Technician

. Successfully developed flow of prescriptions form the point of drop

off to the pick up

. Labeled and returned expired drugs in timely manner to maintain the

inventory

. Applied pricing, patent and marketing knowledge to provide cost

effective patient care

. Communicated with appropriate personnel regarding drug distribution

and cost issues

Beacon Pharmacy, Port Washington, NY (June 2007 - June 2009) (Full time)

(September 2011 - Present) (Part Time)

Pharmacy Technician

. Confirmed that the information on the prescriptions are accurate and

interpreted the doctors' medication order

. Retrieved correct medication for counting, pouring, weighing and

measuring as detailed on the prescription. Appropriately packed the

medication, prepared prescription labels and information about the

prescribed medication for the patient read

. Maintained inventory based on demand, expired or recalled products

Zydus cadilla Healthcare Ltd. India (May, 2005 - November, 2006)

Formulation Associate

. Investigate Existing Patent by the Manufacturer and Develop accordingly

Non-Infringed Dosage Formulation

. Checked for any existing Competitor's Product, their Strengths, Procedure

for Filing, Inactive, Code of Bioequivalence and Tablet Feature

. Performed Brand Innovator Characterization

. Developed our Companies Therapeutic Equivalent Look a Like Generic

Product as per Inactive Ingredient Guide, Brand Innovators Product, SUPAC

(Scale-up and Post approval Changes) Guideline for all the Strength

. Performed Pre-formulation Studies of Drug and inactive (Compatibility

Studies)

. Prepared Master Formula, as per Ingredients Daily Limits specified in IIG

and as per Compatibility with Drug

. Developed Formula for all strength in order to get the Bio equivalent

Drug Products

. Developed R&D Batch, Stability Batch, Pilot Plant Scale-Up Batch,

Optimized Batch and Exhibit Batch of given Drug and to Match the

Dissolution Profile

Astral Pharmaceuticals, India (April 2004 - March 2005)

Formulation Intern

. Observed each and every step done based on GMP and GLP based on USP in

the production of Penicillin tablets USP

. Observed the function of the turbine mixture, Fluid bed mixture, and

Fluid bed dryer

. Use of different sieve to finalize the size of the powders to be used in

the formulation of Penicillin Tablets

. Got general idea of the Formula from which the Penicillin Tablets are to

be made

EDUCATION:

Long Island University, Brooklyn, NY (January 2007- May 2009)

. Masters in Industrial Pharmacy

. Over all GPA 3.53

A.R. College of Pharmacy, Vidhyanagar, India (October 2002- May 2006)

. Bachelor of Pharmacy

. GPA 3.93 out of 4.00

Licensure and Certification:

. Registered Pharmacist in India

. Certified Pharmacy Technician (Pharmacy Technician Certification Board)

Immigration Status: United States Citizen

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