PROFILE

. Twelve (**) years of 'hands on' and supervisory experience in

Formulation Development, Pre-formulation, Stability, Scale up, Pilot

batch, Reformulation, Bio batches, Tech transfer and documentation of

products.

. Developed different type of formulation such as Wet / dry granulation,

Compression coated tablets, Speronization and beads coating,

Controlled release, Liquids and Semisolids.

. Hands on experience on different manufacturing equipments such as high

shear granulator, compactor, different compression and coating

machine, fluid bed coater as well as analytical equipment dissolution

appts, UV-VIS, HPLC, DSC and PAT.

. Knowledge and Understanding of guidelines such as SUPAC, FDA, HBFBI,

Patent evaluation, Bio equivalence and ICH.

EMPLOYMENT HISTORY

PEOCESS ENGINEERING SPECIALIST

TEVA CANADA MAR 2009 - Current

. Lead and execute projects such as process improvements, scale-ups and

scale-down of existing products to Manufacturing

. Supervise one (1) Technologist; Designs manufacturing processes for new

products and reformulation of existing products

. Develop and/or execute experimental designs and approaches to resolve

complex technical problems and accomplish project goals.

. Organize and execute qualifications for alternate suppliers of API and

exicipents

. Provide technical support for validation of commercial products, site

transfer products and investigation for regular commercial products

. Reviews /approve validation protocols and reports for In-house as well as

third party products

. Interact with external raw material vendors for production process

improvement projects

. Initiate, review and approve documents for technical services projects

and regulatory submissions such as investigation reports, change request,

protocols and technical services reports, validation report and

commercial as well as technical services master batch records

. Monitor manufacturing and submission batches related to scale-up/down,

alternate equipment, alternate API and reformulation for US, Canada and

Israel market

. Lead multi-functional Root Cause Analysis Investigations for major

process/product related and implement corrective actions.

. Assist staff and guide for meeting their goals and interact with other

department to resolve any issues

. Represent TS department for steering meeting group for technical

services project discussion

. Works only under general direction and able to work in a team based

organization

FORMULATION SCIENTIST

TEVA NOVOPHARM, CANADA SEPT 2008 - MAR 2009

. Supervise five (5) Technologists and provide necessary input for

executing development trial and submission batches

. Search literatures and patents to establish the appropriate formula and

process

. Search for exicipents suppliers for the formulation development

. Design pre formulation studies and formulation development trials for new

product development for conventional as well as controlled release dosage

forms

. Design, issue and evaluate formulation trials to develop formula and

manufacturing processes

. Coordinates and executes assigned projects and activities; develops

project goals.

. Review, write protocols and batch records to carry out process

development for scale up and pivotal batch manufacturing for Abbreviated

New Drug Applications (ANDA's) submission to regulatory agency.

. Evaluate formulation trials and analytical data and discuss with manager

to decide on the further formulation development

. Prepare biweekly development summary, bio results and present at

formulation meeting with R&D group

Provides scientific and technical directions to Technicians to ensure

project deadlines and standards are met

. Evaluates the bioequivalence data discussion meeting and recommend

changes in formulation.

. Prepare and present formulation development report at pre submission

meeting with technical services

. Prepares pharmaceutical product development report (PDR) and Quality

overall Summary (QOS) for Abbreviated New Drug Applications (ANDA's)

submission to regulatory agency

SCIENTIFIC LEADER FORMULATION DEVELOPMENT NEW PRODUCTS,

APOTEX PHARMACEUTICAL INC, CANADA AUG 2007 - SEPT 2008

. Indirectly supervise up to ten (10) Technicians; executing development

trial, optimization and submission batches

. Search literatures and patents to establish the appropriate formula and

process

. Search for exicipents suppliers for the formulation development

. Design pre formulation studies and formulation development trials for new

product development

. Design, issue and evaluate formulation trials for formula and

manufacturing processes

. Schedule and coordinate all formulation development activities including

initial to submission batches to ensure that projects are completed on

target time

. Evaluate formulation and analytical data and discuss with manager to

decide on the further formulation development

. Trouble-shoot and scale-up the Formula/Processes based on scientific

approach

. Prepare biweekly reports and meeting with management

. Review and approve formulation development master documents and

commercial Scale-up documents

. Compile formulation data and assist cross functional teams for deficiency

reply to regulatory agency

. Co-ordinate and attend cross functional meeting

FORMULATION SCIENTIST, COBALT PHARMACEUTICAL, CANADA AUG 2006 - AUG 2007

. Reporting to the Director of R&D, supervise one (1) R&D Assistant

. Execute manufacturing processes in accordance with manufacturing Batch

records

. Search literature to establish the appropriate formula/process

. Search for API and exicipents suppliers for the formulation

development

. Search for new equipments and processing and ordering for formulation

lab

. Co-ordinate with engineering for IQ/OQ and calibration of the new

equipment installations

. Design pre formulation studies and formulation development trials for

new product development

. Report Formulation activities, coordinate analytical laboratory

testing and report results

. Prepare weekly reports and meeting with analytical department

. Prepare development report

. Evaluation of tech-transfer project and necessary scale-up trials

. Project manager for PAT project

MANUFACTURING OPERATOR, COBALT PHARMACEUTICAL, CANADA FEB 2006 - AUG 2006

. Perform Dispensing of manufacturing batches as per Standard operating

procedure and Bill of material

. Perform machine, changeover, cleaning and set up as required

. Operate various manufacturing equipment of Granulation, Blending and

Coating area and ensure adherence to quality standards

during all stages of the manufacturing process

. Complete manufacturing documents, ensuring accuracy with compliance at

all times with related SOPs and GMPs in the

manufacturing process

. Perform and coordinate Process validation of new product manufacture

. Assist and support team member for manufacturing and validation

batches

. Cleaning and sanitization of equipment and manufacturing room

EXECUTIVE R&D, [Scientist Group Leader]

OMAN PHARMACEUTICAL PRODUCTS, OMAN DEC 2003 - SEPT

2004

. Preparation of Standard Operating Procedures and Work instruction

procedures to ensure product quality

. Design pre formulation studies and formulation development for new

product development

. Preparation of master, batch manufacturing and product specifications

. Scale up of Solid, Semisolid, Liquid and Sustain release Formulations

. Assist teams member for new product development, lab scale, pilot,

stability, and full scale batches of solid dose, Semisolid and liquid

formulations

. Vender development of Active pharmaceutical Ingredients & Non Active

pharmaceutical Ingredients

. Assist and support manufacturing team for product process transfer and

manufacturing

EXECUTIVE R&D, [Scientist Group Leader]

DR.REDDY'S LABORATORIES, INDIA OCT 2002 - DEC

2003

. Supervised six (6) Scientists; responsible for training,

couching and performance reviews

. Preparation of Standard Operating Procedures, Departmental

Operating Procedures and Work instruction to ensure product

quality

. Plan and Design pre formulation studies and formulation

development for new product with formulations scientist

. Formulation Development and Scale up of Solid, Semisolid, Liquid

and Sustain release Formulations such as Tablet, capsule,

ointment,

liquids pellets and gels

. Team member for new product development, lab scale, pilot,

stability, bio, and full scale batches of solid dose products

. Assist technology transfer and Validation team for Manufacturing

of New product and trouble shooting for large production

batches.

. Vender development of Active pharmaceutical Ingredients and Non

Active pharmaceutical Ingredients

. Organized technical meeting for New Product launch at launch

location. Worked with New product development team for

Successful

manufacture and transfer of New Products

. Worked and supported Regulatory team for necessary documentation

and successful submission of New Products

SCIENTIST I, EMCURE PHARMACEUTICAL, INDIA DEC 1998 -

SEPT 2002

. Preparation of Standard Operating Procedures and Departmental Operating

Procedures to ensure product quality

. Preparation of protocol for Pre-formulation, Development, stability and

Product, Finished specification and for the Various products

. Design pre formulation studies and formulation development for new

product development

. Formulation and Analytical development of Solid, Semisolid, Liquid,

tastes improvement, Pellets and fast dissolving formulations

. Develop and manufacturer products at third party contract location

. Perform HPLC, UV and Dissolution and stability testing

. Developed Tablet in Tablet and Bi-layer as well as sustained release

products

EDUCATION

3 Masters in Pharmacy [Pharmaceutics] 1997-

2000

KLES' College of Pharmacy, Belgaum Rajiv Gandhi University of Health

Sciences, India

Dissertation: Development of Mucoadhesive tablets for Oral controlled

release of Astemizole

. Bachelor of Pharmacy

1992- 1996

A.B.C.P College of Pharmacy, India

COMPUTER SOFTWARE SKILLS

. MS office (Excel, Word, Power Point, Access and MS Outlook)

. Hands of experience on SAP, Oracle, Lims and other internal software

System

. Hands of experience on Gastro plus, Cpk and PAT analysis

. Completed white belt for Six Sigma

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