Praveen Sharma Page * of *

CURRICULUM VITAE

Name: - Dr. Praveen Sharma

E-Mail: - acxowp@r.postjobfree.com

CAREER OBJECTIVE

To carve a niche for myself as a Human Being and to work to my full potential in the highest interest of the organization indulging myself in the challenging and responsible field, applying my personal skills and ideas to the best of my ability. Looking for challenging career, where there is scope of demonstration, always on a lookout for a positive and bigger outlook.

VISION

Currency are ideas, thrive on imagination and passion.

Rigorous thinking and boundless curiosity, sets level and standards that exceeds expectation.

Bottom line rises with the organization, a learner for life.

Challenges are what we seek, passion is what we put and success is what we deliver.

The future belongs to those who believe in the beauty of their dreams. AFFILIATION

From November 2014 working at Pfizer Inc., a global biopharmaceutical company, leader in biosimilars & injectables.

03 year experience at Sandoz Private Limited, (a Novartis Group Company), a global innovative healthcare company (Dec 2011 to Nov 2014).

02 year experience at Jubilant Lifesciences Limited.(Dec 2009 to Dec 2011)

02 year experience at Lupin Limited. (Dec 2007 to Dec 2009) Praveen Sharma Page 2 of 9

CAREER RECITAL

Pfizer Inc. Aurangabad ; Chief Research Scientist @ API-TG, Global Technical Services

Investigation Lead on Site to identify the exact root cause for any challenge related to quality (OOS / OOT) of APIs Intermediates or Events during operations / analysis / stability stations by applying DMAIC principle (Lean Technology) & proposing an appropriate CAPA for the same.

Providing technical inputs across diverse spectrum of operations for addressal.

Actively engaged in maintaining site ER/LR status as per Pfizer Quality management System (PQMS).

Successfully faced USFDA audit recently.

Preparation of presentations / investigation reports / development reports / process packages, technology transfer documents.

Execute a key project - process improvement project for an API step.

Knowledge Management Champion for the site ;

Coordinate with global team across Global Technical Services (GTS) to ensure various knowledge management tools are rolled out smoothly in phased manner for the function:

Colleague findability tools connecting people to people like WebEx, SkillsFinder, MyProfile, ASK.

Literature (patents/publications/articles) search tools like e-Library and Scifinder

Zero Defect Tool : ZDT

Electronic Notebook eLN

Perform Knowledge Management (KM) Mapping exercise to understand how the knowledge is retained in i-nexus, ZDT, GDMS, PI, PDOCS, PUPs tools etc.

Pfizer Human Performance Tool PHP.

Safety & Quality Excellence Team Champion for the site.

Member of Internal Audit Team.

Consolidation / tracking of key site projects Global Technical Services (GTS), lab improvements, OH cost reduction programs, COGS reduction programs.

Conducts & leads CFTs meet to discuss & address any issues.

Maintain functional goals/objectives.

Building out and maintaining reliability room and process.

Updates for weekly API Report, Monthly Report, Monthly SLT meeting.

Preparing departmental SOPs & imparting training for the same.

Establishing new processes, demonstrating the same on commercial scale, supporting RA in filing in different geographies.

Addresses Regulatory Deficiency Queries for smooth filing of the molecules. Praveen Sharma Page 3 of 9

Sandoz Private Limited, (a Novartis Company) Mahad ; Senior Scientist @ Technical Life Cycle Management (TLCM) & Manufacturing Science & Technology (MS&T)

Hands on experience to develop a full-fledged R&D facility with complete infrastructure and other related functions from basic stages.

Leading the team of R&D / Scientists towards delivery of New APIs / improved process for existing commercialized molecules with competitive cost while complying with Novartis guidelines of High product quality, HSE, GLP & regulatory requirements.

Drives Life Cycle Management of APIs and ensures cost competitiveness & capacities. Continuously and proactively assesses strategic importance of products portfolio based on the changing environment and expected future APIs coming from the development pipeline.

Ensure smooth tech transfer from lab scale to plant scale and project management.

Manage, lead, motivate, train and develop a team of Scientist and scientific staff & managing healthy work environment with high work ethics.

Review projects periodically and to de-bottleneck by providing regular technical inputs.

Allocate the group’s resources in accordance with project priorities based on discussion with company management.

Trouble-shoot cross-functional issues with the management, functional heads and other stakeholders (QA/QC/Markets, Manufacturing etc.).

Budgeting Revenue & CAPEX and drive the team to meet the same.

Responsible for RMC control for R&D projects.

Provide leadership/management within the department through a structured process of scientific staff recruitments, objective setting, performance appraisal and individual development. As such responsible for improving overall productivity and efficiency.

Responsible for IPM by interaction with IPR team.

To ensure timely switch from “First In” to “Last Out” processes for APIs.

Continuously monitors TPC ́s, collects external bench mark data and proactively addresses needs for TPC improvement programs.

Involve in full development process, regulatory approval and commercial launch of API for regulated markets

Preparation/Review of necessary technical documents/ Drug Development reports/Quality risk assessment report/Synthesis Process Package for filing of the product to various health authorities like USFDA, MHRA, WHO, TGA etc.

Genotoxic assessment & evaluation for the process in collaboration with Toxicological group.

Impurity preparation & characterization by NMR, MASS, IR etc.

Design of experiments & process scale-up by using ASPENTECH & DYNOCHEM Software.

Stability studies and comparison with innovator samples.

Carry over studies & specification preparation, support to the analytical team for analytical method development/validation.

Process Safety Analysis by means of Calorimetric & DSC studies before transferring to plant.

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Notable Highlights

Successfully completed the development, optimization & cost-effective process of Silodosin as well as technology transfer from Lab scale to plant.

Lab Development of Ylide (J6), side chain of Rosuvastatin.

Successfully completed the development, optimization & cost-effective process of Rosuvastatin as well as flawless technology transfer from Lab scale to plant.

Addressed the Deficiencies of US & EU DMF for Rosuvastatin & Silodosin as per QbD.

Development & optimization of Escitalopram oxalate.

Thorough knowledge regarding applying the principles of Quality by Design (QbD) in Departmental projects.

Preparation of development reports / process packages, technology transfer documents.

To support & execute the developments through scale up with monitoring the batches.

To prepare, impart training & follow the SOPs of the department.

Costing of the projects.

To align with Cross Functional Teams (CFTs) of all concerned department of the location as well as Global to address any issue & to resolve the same with harmonized approach.

To collect literature for development / improvement in the processes generating new ideas using tools such as Scifinder, Reaxys etc.

Commissioned new R&D lab and established systems, processes, SOP’s for smooth running of R&D function.

Gained expertise towards Vendor Development, Outsourcing of intermediates, planning of validation batches and scheduling.

Established and sustained effective communication with Vendor/Customer. Manufacturing Science & Technology (MS&T)

Assigned MS&T responsibilities of the location to check the commercial process remains in a state of control i.e. align with the validation campaign in terms of yield & quality.

Preparation of MS&T Documents:

Continued Process Verification (CPV) Documents viz. location SOPs, Protocols & Reports in alignment with Global Team.

Member of Manufacturing Robustness Review Board (MRRB) of the location.

For MS&T initiative declared a “Product Steward” for Silodosin, Rosuvastatin Calcium

& Clopidogrel Hydrochloride: i.e. a technical expert for the project to monitor the critical quality attributes (CQAs) & the factors influencing them viz. Critical Material Attributes

& Critical Process Parameters (CMAs & CPPs) during validation batches in plant as well as to check the robustness of the process during commercial campaign. Major Accountabilities as Manufacturing Robustness Review Board (MRRB) member

Summary of Process performance and product conformity from CPV activities.

Summary of batches produced which did not follow manufacturing instructions and met or did not meet specifications

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Evaluation of process stability (rule violations in control charts, change points).

Evaluation of process capability

Analysis of current production and process measurement systems including evaluation of measurement system variability in relation to process variability / specification limits

Product yield analysis, review of deviations and main investigations.

A review of recent and planned process changes.

Discussion of appropriate priority for product or process improvement projects

Ensure technical excellence in ongoing production and future improvements. Major Accountabilities as Product Steward

Process/product oversight and knowledge:

Maintain the oversight of the process of the product(s) assigned ‘door to door’ at the Site

(e.g. from raw materials to primary packaging).

Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer from development to date. Single Point of Contact to Global Product Steward:

Liaise with Global Product Steward at global level and locally with functions (Quality Assurance QA, Quality Control QC, Engineering, Regulatory Chemistry Manufacturing

& Controls (Reg. CMC), etc), production management (e.g. Process Support Lead, Facilitator, etc), shopfloor (e.g. Operators, Coordinator, etc), with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product in constant state of validation.

Create and maintain a product specific Quality Risk Analysis (QRAs). Continued Process Verification (CPV), data trending and statistical analysis:

Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc.) using statistical analysis and conducting regular product specific data trending.

Utilize data trending and statistical analysis to:

Deepen and broaden process understanding and knowledge.

Detect issues in process capability, such as systematic quality defects.

Identify trends of process deviations (e.g. deviation with common root cause).

Issue quarterly/annual data trending report.

Assist initiating the product-specific monitoring of all critical In Process Controls

(IPC) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis).

Ensure data and trending is visible and communicated at shopfloor level. Praveen Sharma Page 6 of 9

Transfer OUT process:

Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.

Investigations/improvement on product:

Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.

Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritized and monitored.

Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical.

Jubilant LifeSciences Limited, Noida ; Research Scientist @ CRD

Successfully completed the development, optimization & cost-effective process of Rosuvastatin as well as technology transfer from Lab scale to plant.

Successfully completed the development & tech transfer of Fexofenadine hydrochloride.

Developed a novel process for preparation of morph for Japanese market.

Successfully completed the scale up operations of intermediates of Galantamine hydrobromide at outsourcing location.

Developed the process for Omeprazole failing in description. Lupin Limited, Mandideep ; Executive Research & Development @ PDL

Process development (for cost reduction and for quality improvement) and capacity improvement of cardiovascular drugs like Ramipril, Quinapril hydrochloride and Perindopril Erbumine.

Developed an efficient and cost effective manufacturing process of Quinapril hydrochloride and Perindopril Erbumine for regulated market.

Evaluation and investigation of any batch failure (yield and/or quality) and stability failure (of API).

Support to plant to achieve the budgeted efficiencies of the cardiovascular drugs such as Ramipril, Quinapril hydrochloride, Perindopril Erbumine, Trandolapril & Benazepril hydrochloride.

Preparation of impurities and working standards and providing the same to ARD.

Technology Transfer of cardiovascular Prils Perindopril Erbumine & Benazepril Hydrochloride.

Successfully faced USFDA audit at Lupin Limited. Praveen Sharma Page 7 of 9

EDUCATIONAL RECORDS

May 2008 Doctor of Philosophy, Ph.D. in Chemistry on the topic entitled "Synthesis and Structural Studies on the Heavy Metal Ions with Derivatives of Organic Compounds” from C.C.S. University, Meerut.

June 2002 Master of Science (Specialization - Organic Chemistry) from N.A.S. (P.G.) College (C.C.S. University, Meerut) with 65.4 %.

June 2000 Bachelor of Science with Chemistry, Botany and Zoology from Meerut College Meerut (C.C.S. University, Meerut) with 64.6 %.

S.S.C. in 1996 with English, Hindi, Physics, Chemistry, Biology from St. Mary's Academy, Meerut Cantt (I.S.C.E. Board) with 79.0%.

H.S.C. in 1994 with English, Hindi, Mathematics, Science (Physics, Chemistry, Biology), History-Civics, Geography and Economics from St. Thomas English Medium School, Meerut (I.C.S.E. Board) with 79.0%.

CERTIFICATIONS & TRAININGS

Operational Excellence: Six-Sigma Method-1 Training (Yellow Belt) by Pfizer Global.

Certified for CAPA investigation by PATHWISE INC. for Hospira, a Pfizer Company.

Certified as Train the Trainer for Site, by Pfizer Global.

Certified for Design of Experiments (DoE) Training by SSA Solutions.

Certified for PRORA (Process Risk Analysis) by Sandoz Global.

Certified as Train the Trainer for Sandoz by Insight Systems Inc.

Certified Minitab (Validation statistical tool for Pharma Industry) Training.

DuPont STOP Training.

COMPUTER SKILLS

Well versed in Microsoft Office Tools viz. Word, Excel and PowerPoint.

Proficient in Minitab Software, Chemdraw.

LANGUAGES

Hindi : Speaking, Reading and Writing – Mother Tongue

English : Speaking, Reading and Writing – Excellent

Marathi : Basic Understanding

Sanskrit : Extremely Basic

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AWARDS & RECOGNITION

Recipient of Sandoz Gems Award for Outstanding Performance for Development, optimization & flawless technology transfer of Rosuvastatin.

Recipient of Spot-on Award at Jubilant LifeSciences Limited for valuable contribution for tech transfer of Galantamine HBr at outsourcing location. CO-CURRICULAR ACTIVITIES

Presentations, Elocution, Debates, Extempore, Member of the organizing committee of cultural events of my college.

HOBBIES

Listening music, watching cricket matches.

Reading some critics & editorial section, reading & listening news and views related to financial sector and financial services.

Watching kids playing in the evening as their innocence gives tremendous relief to the soul.

Exploring internet for latest research updates fascinates me a lot. ABOUT MYSELF

I am optimistic, practical, committed, punctual & straightforward in my approach for life.

Excellent communications skills incorporated with good computational skills.

I believe sharing of happiness increases it many fold, sharing of sorrows rekindles the sagging spirit, strength of character can fight against all odds, determination and hard work is the key to success.

PERSONAL DETAILS

Date of birth: April 01, 1980

Marital Status: Married

Gender : Male

Nationality: Indian

Permanent Address: A-47, Shastrinagar, Meerut (U.P.)-250004

Passport No: Z3605272

Contact No: 089********

Praveen Sharma Page 9 of 9

REFERENCES

(i) Dr. Frank Wetterich

Global Head Technical Life Cycle Management (TLCM), Sandoz GmbH, Holzkirchen

(Munich, Germany)

Contact No. : - +49-162*******

Email: - acxowp@r.postjobfree.com

(ii) Dr. Dominic Desouza

Manager Region Asia Pacific, Commercial Operations Anti-Infectives Sandoz GmbH

(Kundl, Austria)

Contact No. : - +49-173*******

Email: - acxowp@r.postjobfree.com

(iii) Dr. Apurba Chetia

Head Technical Life Cycle Management (TLCM), Sandoz Private. Limited,

(Mahad, India)

Contact No. : - +91-839*******

Email: - acxowp@r.postjobfree.com

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