Development Manufacturing

**** ****** *******, *** - **** . lAWRENCEVILLE .ga, US 30043

Phone (01-917-***-**** . E-mail : abihle@r.postjobfree.com

Jigisha Varia

OBJECTIVE

I am interested in a research based career wherein

I can utilize my formulation skills and strong

pharmaceutical background to accomplish

organizational objectives.

Summary

Formulation scientist with 7 years in

pharmaceutical development. Experienced in

immediate release and controlled release dosage

forms. Self motivated, good written and oral

skills. Communicates effectively and works well

with others in complex teams. A strong academic

background with M.S in Pharmaceutical Technology.

Accomplishments include:

Three IND 505b(2) successfully filled with FDA for

solid oral dosage form and injectable formulation

dosages form, including manufacturing of clinical

supplies for an NDA product.

Designed and executed formulation strategies for

development of generic pharmaceutical product ANDA

of solid oral dosage forms including controlled

release and immediate release. Carried out product

development, stability, scale-up and pivotal batch

manufacturing. Completed bioequivalence studies on

drug product.

Participated in preparation and review of CMC and

QOS for ANDA/IND dossier submission in e-CTD

format.

Contributed to develop and optimize a patent

protected spray drying technology to improve

solubility and bioavailability of hydrophobic

active. Patent application filed on spray drying

technology to improve bioavailability.

Professional experience

January 2009 to Till date ; Revogenex Inc, Winder,

GA

Formulation scientist, Product Development, R & D

Responsible for providing strategy and leadership

in formulation development activities including

preformulation, prototype formula design, product

optimization, process development and product

stability, manufacturing and scale up.

Responsible for life cycle management and potential

IP opportunities for the new products and existing

products including development of drug delivery

systems and new platform technology.

Responsible for development of NDA 505b (2)

products and preparation of documents required for

the FDA submissions as per FDA guidelines.

Success track record of filing 3 INDs in eCTD

format. with USFDA

Responsible for manufacturing of IND products for

Phase I, II and phase III clinical trials under

cGMP conditions. Prepare necessary documentation

for in vivo/in vitro screening.

Preparation and review of pharmaceutical product

development report (PDR), batch records, stability

and process validation protocols, CMC (Drug

substance, drug product and manufacturing process),

Quality overall Summary (QOS) and other necessary

documents to support regulatory filing of IND and

ANDAs.

Responsible for scale up, technology transfer and

troubleshooting at commercial manufacturing.

Oct 2008 to January 2009 ; Bio-pharm Inc,

Levittown, PA

Formulation scientist (Formulation Development)

Responsibilities included formulation

design and development of stable and

bio-Equivalent solid and liquid oral dosage forms,

generate and maintain all documents like batch

records, protocols, and product development

reports etc. related to formulations.

Accountable for the presenting project status and

practical data in front of senior management.

Responsible for the pilot scale up and technology

transfer to the manufacturing.

March 2004 to May 2008; Alembic Limited, India.

Research Scientist (Formulation Development)

Responsibilities include formulation development of

stable and bio-Equivalent 'immediate Release,

delayed Release and sustain release solid oral

dosage forms' and performing tasks associated

with wide range of formulation types and process

operations which includes granulation, drying,

tablet manufacturing, IR bead manufacture,

coating, taste masking and encapsulation, solution

and suspension products.

Worked on development of drug delivery system and

platform technology to improve stability,

solubility and bioavailability of small drug

molecules.

Responsible for managing all aspects of the

technical transfer process from R&D to

manufacturing including technical support in the

optimization of new and current processes as per

SUPAC guidelines.

Responsible for preparation and reviewing of

technical documents which includes batch records,

product development report as per QBR, stability

and sampling protocols, technology transfer

documents.

Experienced in collaborating with cross-functional

groups (analytical development, process

development, QC, QA, clinical, marketing, supply

chain, Legal) as well as contract manufacturing

and research organizations.

Worked as team member and to actively participate

in achieving the aims and goals of the R&D group

and project teams.

Improvement of existing formulations for cost

reduction.

Sep 2001 to July 2002; Sun Pharmaceutical Advance

Research Center

Contract Project (Medical Department)

All clinical research related activities as per the

ICH GCP guidelines.

Maintaining all documentation for Trial Master

File.

Coordinating with Medical Service Team.

Academic Accomplishment

Academic Project work involves the improvement of

oral bioavailability of cyclosporine using

lipid-based drug delivery systems -Solid lipid

nanoparticles (SLN) and self-emulsifying drug

delivery system (SEDDS). Research experience also

involves expertise in handling sophisticated

instruments used in the development of

pharmaceutical dosages form.

Qualified GATE- 2002 with 95.32 percentile

conducted by Indian Institute of Science, Bangalore

- 560012

publications

Cyclosporine a loaded lipid nanoparticles:

optimization of formulation, process variable and

characterization, Current Drug Delivery, 5, (1),

January, 64-69, 2008

Cyclosporine loaded solid lipid nanoparticles

(SLN), 55th Indian Pharmaceutical Congress,

Chennai, 19th -21st Dec 2003.

Design and optimization of Solid Lipid

Nanoparticles (SLN) of Cyclosporine, National

Symposium on Science Technology& Applications of

Nanomaterials, M S University of Baroda, Vadodara,

21-22 March, 2005.

Formulation and invitro and in vivo evaluation of

SEDDS of Cyclosporine, National Symposium on

Exploring Nanotechnology in Drug Delivery, Pharmacy

Department, M S University of Baroda, Vadodara,

29th -30th July 2005

Formulation, optimization and characterization of

Cyclosporine loaded solid lipid nanoparticles with

two different lipids, (AP-149), 57th Indian

Pharmaceutical Congress, Hyderabad, 2-4 Dec 2005.

Education

Master of Pharmacy in Pharmaceutical Technology

January 2002 to February 2004 at M.S University,

Baroda.

Bachelor of Pharmacy

September 1997 to Aug 2001 at M.S University,

Baroda

References

Available Upon Request

Jigisha Varia

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