Manu Sharma Mobile: +91-981******* E-Mail:

acn0rk@r.postjobfree.com [pic]

A BRIEF SYNOPSIS

A competitive, responsible, self starter, disciplined and goal oriented

professional with 8+ years of experience in Formulation Research &

Development including Project Planning, Process Management, Documentation,

Quality and Compliance. Successfully demonstrated several years of

experience in Pharmaceutical Science and Technology. Thorough understanding

of development processes in a specific function. Ability to lead team.

During the eight years of experience worked majorly on product development

for US and Canada Market.

Scope of development involved:

. Immediate release dosage forms

. Extended Release Hydrophilic matrix system with 24 hours release

profile

. Solid dispersions

. Powder for oral suspension

. Hydrophilic matrix system using sodium alginate as a polymer with 8

hours of profile.

. Successfully transferred the technology from R&D scale to plant scale

for products developed during eight year's tenure

CAREER OBJECTIVE

Seeking professional enrichments in with leading organisation and grow as a

leader to take on challenging responsibilities in the areas of Research and

Development, Regulatory Affairs.

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PROFESSIONAL EXPERIENCE

Working in Ranbaxy since September 2006

Currently Senior Research Scientist (A3), RANBAXY Research Laboratories,

Gurgaon.

Career Progression in Ranbaxy

Research Associate September 2006 August 2008

Research Scientist(A1) August 2008 Dec 2010

Senior Research Dec 2010 July 2013

Scientist(A2)

Senior Research July 2013 Till date

Scientist(A3)

JOB PROFILE

Research and Development

. Development of conventional dosage forms like solids, Extended release

tablets using hydrophilic matrix type of system, semi solids for US,

Canada and Japan Market.

. Development of Generics for Antihypertensive, Antihistamine, Anti

diabetics, Anti cancer, Antibiotics and Lipid lowering class of drugs

including pre-formulation studies, formulation development and process

optimization using QBD approach as per the latest template, stability

profiling and transfer of the technology to the shop-floor (including

scale-up/exhibit batches for US and Canada market).

. Trouble-shooting of commercialized products.

. Site transfer of commercialized products.

. Successful technology transfer of products from R&D to plant locations

(Ohms lab USA, Poanta, Dewas and Mohali).

Job Description

1. Literature Search which includes Summary basis of analysis, SPC and

Patent information.

2. Strategy Development: Based on the literature search IP strategy

for formulation and process is done.

3. Reference product characterization (Reverse engineering) and

defining QTPP for test product.

4. Pre-formulation studies which includes Compatibility studies,

Solubility studies, Microscopy to determine particle shape, pKa of

API particle size etc.

5. Defining Drug product Critical quality attributes for test product

based on QTPP and Literature search and Prior ANDA knowledge.

6. Risk assessment of drug substance attributes which can impact drug

product CQA's

7. Prototype formulation and process development keeping in mind

commercial viability of the process chosen.

8. Identification of bio discriminatory media

9. Fabrication of Pilot BE batch and Review of BE protocol.

10. Risk assessment of Formulation variables which can impact drug

product DP CQA's.

11. Optimization of formulation using DOE approach.

12. Risk assessment of process variables which can impact drug product

CQA's

13. Optimization of process using DOE approach.

14. Development of Technology transfer dossier which includes IP, PR

and FP specifications for drug product, manufacturing instructions,

MFC, Formulation Order, Stability protocol and development report.

Stability data of stage-II batches at both long term and

accelerated conditions.

15. TTD review from quality department

16. Support for Preparation of Scale up protocol, Scale up report,

BPR's and TBMR.

17. Scale UP and Exhibit batches for test product.

18. Development of control strategy.

19. Review of Pivotal BE protocol.

20. Support for filling of drug product with regulatory agency.

21. Response to query received from regulatory agency.

22. Support for maintenance and SOP preparation for various equipments

in the department.

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Project Planning

. Maintaining scientific excellence and creating intellectual property.

. Preparing and finalizing requirements and specifications.

. Evaluating project progress.

. Development report preparation using QBD approach as per the latest

template

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Process Management

. Co-ordinating with different departments to develop integrated sets of

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Documentation / Quality Compliance

. Preparing and finalizing Product Development Report using QBD and DOE

approach, including analytical method development while ensuring

compliance.

. Providing scientific inputs in response to regulatory queries for US

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DISTINCTIVE ACCOMPLISHMENTS IN RANBAXY

. Awarded with the Scientist of the Month Award in 2010 for excellent

development and execution of product in minimum time which was must

for company.

. Appreciate award in year 2011 for development and filing of BCS class-

IV molecule.

. Awarded with the Spot Award in 2011 extended release product developed

using hydrophilic matrix type release system.

ACADEMIC CREDENTIALS

2006 M.Pharm (Pharmaceutics)

Punjab University, University institute of Pharmaceutical

sciences (UIPS), Chandigarh

2004 GATE Qualified

2004 B.Pharm

ISF College of Pharmacy, Moga, Punjab Technical University,

Jallandhar

2000 XIIth

From CBSE BOARD. Secured 79.6%

1998 Xth

From CBSE BOARD. Secured 72%

ACADEMIC ACHIEVEMENTS

. Research project during M.Pharm

Solubilization and Bioavailabilty enhancement of poorly soluble drugs

using Microemulsion technique.

. Research papers

- Indian patent filed on solubilisation and Bioavailability

enhancement of poorly soluble drugs using Microemulsion

technique.

ACADEMIC DISTINCTION

. Hold distinction in M.Pharmacy

SPORTS DISTINCTION

. Part of cricket final winning team during UIPS cricket matches

. Bronze medal during National taekwondo championship

. Won Volley ball trophy during B-Pharmacy 2nd year

PERSONAL DOSSIER

Date of birth November 20, 1981

Sex Male

Nationality Indian

Martial Status Married

( H-377, Sector-30, Jalvayu Vihar, Gurgaon

Haryana

Gurgaon 122 002

Permanent Address House no: 511, Sector: 10

Panchkula, Haryana

Phone: 017*-*******

REFERENCE

Mr. Sachin Arora

Principle Scientist

Dr. Reddys Lab, Hyderabad

Mr. Ajay K Singla

Senior Vice President

Agila Mylan, Bangalore

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